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Hepatitis B Clinical Trials

The future is bright for people with chronic hepatitis B, thanks in a large part to advancements in medical science. All drugs must go through a testing process, which involves three phases of clinical trials, to evaluate its safety and effectiveness before being approved.

Volunteering for a clinical trial program can be very valuable. Expensive blood work, treatment medications, and doctor's visits are usually provided free of charge for those accepted into a study. Clinical trials also provide the opportunity to potentially benefit from the latest advances in medical science.

The Hepatitis B Foundation regularly updates this page to provide the most current hepatitis B clinical trial sites in the United States and abroad. Please contact us if you have any questions about clinical trials or know of a drug trial that is not listed.

Click the following links for:

International HBV Clinical Trials, Co-Infection Clinical Trials, Pediatric Clinical Trials, HBV & Liver Transplantation Clinical Trials, HBV & Liver Cancer, HBV Reactivation and Lymphoma and HBV Reactivation With Other Agents


Updated September 13, 2015

U.S. CLINICAL TRIALS

*CHB=Chronic hepatitis B

Identification of CHB Among Somali Immigrants in Minnesota Through Community Wide Screening – U.S. only
This study will fill gaps in the Somali population to determine US immigrant prevalence data and risk factors for HBV and HCV. Contact: Nasra Giama, DNP at 507-538-0097 giama.nasra@mayo.edu or Dr. Lewis Roberts at 507-538-4877 roberts.lewis@mayo.edu and refer to identifier- NCT02366286  (Study ID #09-001670, IN-US-174-0230)

ARC-520 in HBeAg Positive CHB Patients – U.S. only

CHB patients will receive multiple doses of ARC-520 in combination with entecavir or tenofovir and will be evaluated for safety and efficacya. Contact: Medical Director at 626-304-3400 and refer to identifier- NCT02452528  (Study ID #Heparc-2004)

Peginterferon-Alpha Add-on Following Long-Term Nucleos(t)ide Analogue TX in CHB Patients – U.S. only
Study to determine the mechanisms associated with favorable responses to PEG add-on following long-term NA treatment and safety of PEG with these antivirals. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov.  and refer to identifier - NCT02364336 (Study ID # 150082,15-DK-0082)

Long-Term Study of Liver Disease in People w/ Hepatitis B or Hepatitis C – U.S. only
This study will follow hepatitis B and/or hepatitis C to better understand how these viruses affect the immune system over the long-term. Contact: Rachel Newman, RN at 202-857-5219 newmanr2@mail.nih.gov or Dr. Colleen Hadigan at 301-594-5754 hadiganc@mail.nih.gov and refer to identifier - NCT01350648 (Study ID # 110152, 11-CC-0152)

Antiretroviral Pregnancy Registry – U.S. only
Multi-sponsor registry to detect any major teratogenic effect involving any of the registry drugs when administered to pregnant women. Contact: Susan Goodlow at SM_APR@INCResearch.com or call 800-258-4263 or Pam Meador at 800-258-4263 or SM_APR@INCResearch.com and refer to identifier- NCT0040989  (Study ID # APR)

Physiology of Fatigue in Patients with Chronic Liver Disease – U.S. only
Fatigue is a common, often disabling symptom in people with chronic liver disease. This study will look at the causes and mechanism of fatigue in people with chronic liver disease. Contact: Nevitt Morris, RN atnevitt.morris@nih.gov or call 301-496-1665 or Dr. Yaron Rotman at 301-451-6553rotmanyaron@niddk.nih.gov and refer to identifier- NCT01867385  (Study ID #130142, 13-DK-0142)

Phase I Study of INO-1800 With or without INO-9112 +EP in CHB Patients – U.S. and International
Evaluate safety, tolerability and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation in entecavir or tenofovir treated patients. Contact: Jill Tan at +65 660 1228 jill.tan@quintiles.com or Justin Cerandini at +919-998-2936 justin.ceradini@quintiles.com and refer to identifier- NCT02431312 (Study ID# HBV-001)

Tenofovir Alfenamide vs Tenofovir Disoproxil Fumarate for TX of HBeAg (+) Hepatitis B – U.S. and International
Evaluate the safety and efficacy of tenofovir (TAF) compared to that of tenofovir disoproxil fumerate (TDF) in treatment naïve and treatment experienced adults with CHB. Contact: Gilead Study Team at TAF4HBV@gilead.com and refer to identifier- NCT01940471 (Study ID# GS-US-320-0110)

Tenofovir Alfenamide vs Tenofovir Disoproxil Fumarate for TX of HBeAg (-) Hepatitis B – U.S. and International
Evaluate the safety and efficacy of tenofovir (TAF) compared to that of tenofovir disoproxil fumerate (TDF) in treatment naïve and treatment experienced adults with CHB. Contact: Gilead Study Team at TAF4HBV@gilead.com and refer to identifier- NCT01940341 (Study ID# GS-US-320-0108)

Safety and Efficacy of GS-4774 in Combination w/Tenofovir Disproxil Fumarate for the Treatment of CHB of Subjects Currently Not on Treatment  – U.S. and International
Evaluate the safety, tolerability and efficacy of GS-4774 in adults with CHB and who are currently not being treated. Contact: Gilead Study Team at GS-US-330-1401@gilead.com and refer to identifier- NCT02174276 (Study ID# GS-US-330-1401, 2014-001011-39)

Safety and Efficacy of GS-9620 for the Treatment of CHB in Virally-Suppressed Subjects  – U.S. and International
Evaluate the safety, tolerability and efficacy of GS-9620 in virologically suppressed adults with CHB currently being treated w/ oral antivirals. Contact: Gilead Study Team at TLR7-9620@gilead.com and refer to identifier- NCT02166047 (Study ID# GS-US-283-1059, 2014-001-400-22)

HBRN:  Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored trials Combo Therapy of Pegylated interferon Alfa-2a and Tenovfovir vs. Tenofovir monotherapy in CHB (NCT01369212) and Combo Entecavir and Peginterferon Therapy in HBeAg pos immune tolerant adults with CHB (NCT01369199). Study will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN trials NCT01369212 and NCT01369199 to define natural history and treatment outcome.  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier NCT01796457 Study ID # DK082864 HBRN Immunology Treatment, U01DK082864

Tenofovir DF With or Without Peginterferon for CHB – U.S. only
Study to determine whether combining tenofovir DF and peginterferon or using tenofovir DF alone, and which is a more effective treatment for chronic hepatitis B. Contact: Elenita Rivera, RN at 301-496-3531 erivera@cc.nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT01821794 (Study ID # 130091, 13-DK-0091)

Withdrawal of Therapy After Long-Term Antiviral Treatment for CHB  – U.S. only
Withdrawl of therapy after long-term NAT treatment by following HBeAg pos and neg CHB patients to determine the best time to stop treatment and prevent the disease from causing further liver damage. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov. Refer to identifier - NCT01581554  (Study ID#110151, 11-DK-0151)

Observational Study of Persons With Hepatitis B Virus Infection in North America – North America only
Long-term study of those with chronic HBV to improve current knowledge on the disease and long-term disease progression. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT01306071 (Study ID # 110108, 11-DK-0108)

Long-term Study of Liver Disease in Patients with HBV and/or HCV with or w/out HIV – U.S. only
Study to understand how these viruses affect the immune system over the long-term. Annual visit with researcher, but patient must have a primary care doctor. Contact: Rachel E Newman, RN 202-857-5219, newmanr2@mail.nih.gov or Colleen M Hadigan, MD at 301-594-5754 hadiganc@mail.nih.gov Refer to identifier - NCT01350648 (Study ID # 110152, 11-CC-0152)

Evaluation of Patients With Liver Disease – U.S. only
Evaluate, investigate and follow-up patients suffering from acute and chronic liver disease. Qualified patients may be able to participate in other offered studies. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. T. Jake Liang at 301-496-1721 jakel@mail.nih.gov. Refer to identifier - NCT00001971 (Study ID # 910214, 91-DK-0214)

Tenofovir Alone vs. Tenofovir with Emtricitabine for CHB – U.S. Only
Test whether the combination of two medications, tenofovir and emtricitabine are safer and more effective for treating CHB than tenofovir alone. Contact: Elenita Rivera, RN at 301-496-3531 erivera@cc.nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov.and refer to identifier - NCT00524173  (Study ID# 070207, 07-DK-0207)

Combination Peginterferon and Tenofovir vs. Tenofovir in CHB (HBRN) – U.S. and Canada
Trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by tenofovir alone for 3.5 years vs. tenofovir given alone for 4 years in CHB patients. Primary measure of outcome will be HBsAg loss at 48 weeks after stopping all antiviral therapy. Contact: Michelle Danielson, PhD at 412-624-5555 or danielsonm@edc.pitt.edu or Joan MacGregor, MS at 412-624-4300 or macgreg@edc.pitt.edu and refer to identifier - NCT01369212 (Study ID# DK082864 HBRN Immune Active)

Hepatitis B Research Network Adult Cohort Study (HBRN) – U.S. and Canada
A study to identify factors that cause HBV disease to activate or worsen. Contact: Michelle Danielson, PhD at 412-625-5555 or danielsonm@edc.pitt.edu or Joan MacGregor, MS 412-624-4300 at macgreg@edc.pitt.edu and refer to identifier -NCT01263587 (Study ID # DK082864, U01DK082864)

HBRN:  Immune Regulation and Costimulation in Natural History of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored HBRN cohort study that will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN study (NCT01263587).  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier NCT01298037 Study ID # DK082864 HBRN Immunology, U01DK082864

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INTERNATIONAL CLINICAL TRIALS

*CHB=Chronic hepatitis B

Phase I Study of INO-1800 With or without INO-9112 +EP in CHB Patients – U.S. and International
Evaluate safety, tolerability and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation in entecavir or tenofovir treated patients. Contact: Jill Tan at +65 6602 1228 jill.tan@quintiles.com or Justin Cerandini at +919-998-2936 justin.ceradini@quintiles.com and refer to identifier- NCT02431312 (Study ID# HBV-001)

Tenofovir Alfenamide vs Tenofovir Disoproxil Fumarate for TX of HBeAg (+) Hepatitis B – U.S. and International
Evaluate the safety and efficacy of tenofovir (TAF) compared to that of tenofovir disoproxil fumerate (TDF) in treatment naïve and treatment experienced adults with CHB. Contact: Gilead Study Team at TAF4HBV@gilead.com and refer to identifier- NCT01940471 (Study ID# GS-US-320-0110)

Tenofovir Alfenamide vs Tenofovir Disoproxil Fumarate for TX of HBeAg (-) Hepatitis B – U.S. and International

Evaluate the safety and efficacy of tenofovir (TAF) compared to that of tenofovir disoproxil fumerate (TDF) in treatment naïve and treatment experienced adults with CHB. Contact: Gilead Study Team at TAF4HBV@gilead.com and refer to identifier- NCT01940341 (Study ID# GS-US-320-0108)

Safety and Efficacy of GS-4774 in Combination w/Tenofovir Disproxil Fumarate for the Treatment of CHB of Subjects Currently Not on Treatment  – U.S. and International
Evaluate the safety, tolerability and efficacy of GS-4774 in adults with CHB and who are currently not being treated. Contact: Gilead Study Team at GS-US-330-1401@gilead.com and refer to identifier- NCT02174276 (Study ID# GS-US-330-1401, 2014-001011-39)

Safety and Efficacy of GS-9620 for the Treatment of CHB in Virally-Suppressed Subjects  – U.S. and International
Evaluate the safety, tolerability and efficacy of GS-9620 in virologically suppressed adults with CHB currently being treated w/ oral antivirals. Contact: Gilead Study Team at TLR7-9620@gilead.com and refer to identifier- NCT02166047 (Study ID# GS-US-283-1059, 2014-001-400-22)

HBRN:  Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored trials Combo Therapy of Pegylated interferon Alfa-2a and Tenovfovir vs. Tenofovir monotherapy in CHB (NCT01369212) and Combo Entecavir and Peginterferon Therapy in HBeAg pos immune tolerant adults with CHB (NCT01369199). Study will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN trials NCT01369212 and NCT01369199 to define natural history and treatment outcome.  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier NCT01796457 Study ID # DK082864 HBRN Immunology Treatment, U01DK082864

Hepatitis B Research Network Adult Cohort Study (HBRN) – U.S. and Canada
A study to identify factors that cause HBV disease to activate or worsen. Contact: Michelle Danielson, PhD at 412-625-5555 or danielsonm@edc.pitt.edu or Joan MacGregor, MS 412-624-4300 at macgreg@edc.pitt.edu  and refer to identifier -NCT01263587   (Study ID # DK082864, U01DK082864)

HBRN:  Immune Regulation and Costimulation in Natural History of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored HBRN cohort study that will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN study (NCT01263587).  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier - NCT01298037  (Study ID # DK082864 HBRN Immunology, U01DK082864)

Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound – Canada
Cross-sectional study to compare sensitivity of elastographic methods for detecting histology-determined significant fibrosis. Contact: An Tang, MD MSc at 514-890-8000 ext 36400 or an.tang@umontreal.ca  or Assia Belblidia 514-890-8000 ext 34369 at assia.belblidia.chum@ssss.gouv.qc.ca and refer to identifier -NCT02044523 (Study ID # CE12.062)

Observational Study of Persons With Hepatitis B Virus Infection in North America – North America only
Long-term study of those with chronic HBV to improve current knowledge on the disease and long-term disease progression. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT01306071 (Study ID # 110108, 11-DK-0108)

Dose Ranging Study to Assess Safety, Antiviral Efficacy, PK of NVR 3-778 in CHB Patients – International only
Phase 1b trial will assess the dose related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B. Contact Sandy Liaw at sliaw@noviratherapeutics.com and refer to identifier - NCT02401737 (Study ID # NVR3-778-101B)

ABX203 Therapeutic Vaccine Efficacy in HBeAg (-) CHB Patients –  International only
Open-label, randomized, comparative, multicenter trial to assess efficacy of ABX203 in CHB patients currently treated with nucleos(t)ide analogs. Contact: Individual site contacts and refer to identifier- NCT02249988 (Study ID# ABX203-002)

Study of Treatment with RO6864018 in Entecavir Treated Patients with CHB – International only
Randomized, multicenter, partially double-blind, placebo study to evaluate effects of treatment with RO6864018 in virologically suppressed Entecavir treated patients with chronic HBV. Contact: Reference Study ID # NP28938 at www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com. Identifier - NCT02391805 (Study ID # NP28938)

Evaluate Ad5 Neutralizing Antibodies in CHB Patients –  International only
Non-investigational study to identify and preselect CHB patients who are undetectable for anti-Ad5 nAb, currently treated with nucleos(t)ides for participation in TG 1050 Phase 1/1b trials (Transgene) Contact: Transgene EU, Clinical Operations Department at +33(0)3-88-27-91-00 or Transgene Clinical Development at +1-617-679-8000 and refer to identifier- NCT02355951 (Study ID# TG1050.01)

NVR 3-778 in Healthy Volunteers and Hepatitis B Patients –  International only
Phase 1 trial will assess dose-related and PK profile of different doses of NVR 3-778, first in healthy volunteers and subsequently in patients with CHB. Part II, changes in patient serum HBV DNA and other virologic efficacy parameters to be assessed. Contact: Sandy Liaw at sliaw@noviratherapeutics.com and refer to identifier- NCT02112799 (Study ID# NVR3-778-101)

Telbivudine or Tenofovir Treatment in HBeAg (-) CHB Patients based on Roadmap Concept (LDT600A) – International only
Evaluate efficacy and safety following Roadmap Concept – initial monotherapy with Telbivudine or tenofovir in HBeAg (-) CHB patients. Contact:  Novartis Pharmaceuticals at +41-61-324-1111 and refer to identifier NCT01379508 (Study ID # CLDT600A2409)

Sustained Off-TX Response After HBeAg Loss in CHB Treated w/ Nucleos(t)ide Analogues (STOP) – Canada
Learn the effects of discontinuing or continuing nucleos(t)ide analogue treatment (NA) for 72 weeks in CHB patients whose immune system is controlling the virus levels in the blood for at least 12 months of NA therapy. Contact: Dr. Harry Janssen at 416-603-5986, harry.janssen@uhn.ca or Victor Lo, MASc, CCRP at 416-603-5839, victor.lo@uhn.ca. Refer to identifier - NCT01911156 (Study ID # Stop Study, GILEAD Sciences Canada, Inc)

Tenofovir 300mg 3yr RD Therapy Following Multiple NA Failure Points – China
Phase IV trial to assess efficacy of TDF in chronic hepatitis B patients following failure of multiple nucleos(t)ide analogs. Contact: US GSK Clinical Trials Call Center at 877-379-3718 GSKClinicalSupportHD@gsk.com and refer to identifier - NCT02195518 (Study ID # 201215)

Combination Treatment with PolyIC and Entecavir for CHB – China
Investigate the antiviral efficacy of combination treatment with Poly IC and Entecavir and compare with Entecavir monotherapy for CHB. Contact: Dr. Xin Zheng at (00)-86-02785726732 zheng2015uh@163.com, or Jin Tian MS at (00)-86-02785726132 or tjxhj@126.com and refer to identifier - NCT02532413 (Study ID # 81461130019C5)

ShearWave Elastography to Assess Liver Fibrosis in Chinese Patients with CHB – China
Investigate the antiviral efficacy of combination treatment with Poly IC and Entecavir and compare with Entecavir monotherapy for CHB. Contact: Joel Gay +33 4429992424 joel.gay@supersonicimage.com or Holly Zheng at holly.zheng@supersonicimage.com and refer to identifier - NCT02313649 (Study ID # LE2)

Domestic Tenofovir in Chinese CHB Patients– China
Study to evaluate the safety and efficacy of domestic Tenofovir Disoproxil Fumerate in Chinese patients with hepatitis B. Contact: Dr. Yan Yan Yu at 13911405123 yyy@bjnu.edu and refer to identifier - NCT02287857 (Study ID # CTTQ-TDF-V3.0)

Tenofovir (TDF) in Chinese CHB Patients w/Advanced Fibrosis & Compensated Cirrhosis – China
Multi-center cohort open-label study to investigate long-term effect of TDF on prevention of HCC and disease progression, and safety of long-term TDF use in those with advanced liver disease. Contact: US GSK Clinical Trials Call Center at 877-379-3718 GSKClinicalSupportHD@gsk.com and refer to identifier - NCT02224456 (Study ID # 201213)

NA Experienced CHB Patients for Prospective Trial (Anchor) – China
Multi-center, randomized prospective, open label Phase III trial assessing combination and sequential treatment with peginterferon alfa-2b, entecavir and GMCSF in NA experienced CHB patients. Contact: Dr. Qin Ning at 86 27 83662391 qning@vip.sina.com and refer to identifier - NCT02327416 (Study ID # Anchor Study)

Combination Therapy of Interferon Plus Interleuken 2 and Hepatitis B Vaccine in CHB Patients – China

Multicenter, randomized, prospective open label Phase IV trial to evaluate efficacy and safety of interferon (IFN) alpha-2b combined with interleukin 2 and HBV therapeutic vaccine vs. IFN-2b alone in chronic hepatitis B patients with entecavir achieving HBeAg seroclearance. Contact: Dr. Qin Ning at 86-27-83662391 or qning@vip.sina.com, or Dr. Meifang Han at 86-27-83662391 or hanmeifang@hotmail.com and refer to identifier - NCT02360592 (Study ID # Endeavor study)

Observational Study on Patients with Chronic Hepatitis B – China
Study conducted to evaluate the effect of antiviral treatment on long-term outcome on patients with chronic HBV. Contact: Dr. Jinlin Hou at 86-20-61641941 or jhousmu@163.com, or Jian Sun at 86-20-62787432 or doctorsunjian@163.com and refer to identifier - NCT02167503 (Study ID # MOH-08)

Treatment of Liver Cirrhosis Due to Hepatitis B Virus w/ Fuzheng Huayu and Entecavir – China
Establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV. Contact: Dr. Chenghai Liu at 8621-20256521 Chenghailiu@hotmail.com and refer to identifier - NCT02241590 (Study ID # SGHLC20140818001)

Traditional Chinese Medicine Combined with Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV Liver Cirrhosis – China
Establish the safety and efficacy of the combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in liver cirrhosis due to HBV. Contact: Dr. Chenghai Liu at 8621-20256521 Chenghailiu@hotmail.com and refer to identifier - NCT02241616 (Study ID # SGHLC20140818002)

Traditional Chinese Medicine Diagnosis and Treatment Blocking and Reversing HBV Related Fibrosis – China  
Randomized, controlled, double-blind, multi-center trial evaluating optional TCM diagnosis and treatment of HBV liver related fibrosis. Contact: Yongping Yang, Master at 0086-13601371542 or yongpingyang@hotmail.com.  Refer to identifier - NCT01965418 (Study ID # 2013ZX10005002)

Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters – China  
Prospective study used to construct and validate a non-invasive model consisting of biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis as a result of HBV. Contact: Guiqiang Wang at 13911405123 or john131212@126.com or Hong Zhao at 13810765943, minmin2001@gmail.com.  Refer to identifier - NCT01962155 (Study ID # 2013ZX10002005)

Optimized Treatment and Regression of HBV-Induced Compensated Liver Cirrhosis – China  
Patients with HBV induced compensated liver cirrhosis will participate in a study to evaluate entecavir alone, entecavir + thymosin-alpha, for varying durations, etc. Assessed at baseline and every 6 months. Contact: Dr. Hong You at 8610-63139019 or youhong30@sina.com or Dr. Jidong Jia at 8610-63139816, jiamd@263.net.  Refer to identifier - NCT01943617 (Study ID # 2013ZX10002004-3)

Optimized Treatment and Regression of HBV-Induced Early Cirrhosis – China Patients with chronic HBV histologically confirmed with early cirrhosis are randomized in a 1:1 ratio, multi-armed study – entecavir alone, entecavir + thymosin-alpha for varying durations, etc. Assessed at baseline and every 6 months. Contact: Dr. Hong You at 8610-63139019 or youhong30@sina.com or Dr. Jidong Jia at 8610-63139816, jiamd@263.net.  Refer to identifier - NCT01938820 (Study ID # 2013ZX10002004-2)

Combo or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients with CHB – China
Investigate efficacy of combination or sequential therapy using Peginterferon Alfa-2a and entecavir in HBeAg positive chronic hepatitis B patients. Contact: Dr. Sa Lv at 86-10-63879735 ext 2014.12 or lvsa@sina.com and refer to identifier - NCT01906580 (Study ID # 2011030D)

Study in Noninvasive Evaluation of Hepatic Fibrosis in CHB – China
Evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with CHB. Contact: Dr. Hong Zhao at 13810765943 or minmin2001@gmail.com or Dr. Guiqiang Wang at 13911405123 or john131212@126.com and refer to identifier - NCT01679769 (Study ID # 2012-455, 81170386)

Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With CHB Infection– China
Patients are divided into two groups: early and conventional. Patients are followed for 10 yrs. to determine optimal start time for TX.  Contact: Dr. Gao Zhiliang at +862085252037, zhanlianh@21cn.com or Dr. Huang Zhanlian at +8685252046, Zhanlianh@21cn.com and refer to identifier - NCT00810524  (Study ID # Sun Yat-senU 5010 Hepatitis  B)

Treatment of Hepatitis B in Resource-Limited Settings – Pilot Program in East Africa – Ethiopia
The aim of this study is to establish a treatment protocol for hepatitis B, which is simple and inexpensive enough to be implemented in resource limited settings. Contact: Dr. Asgeir Johannessen at +4797983264 johannessen.asgeir@gmail.com Identifier - NCT02344498  (Study ID # 2014/1146)

Follow-up of HBsAg Inactive Carriers Study –France
This study will follow-up with HBsAg inactive carriers for 5 years in order to evaluate the incidence of unfavorable liver events and to evaluate HBsAg quantification. Contact: Marie Muller at 33 2 38 74 42 01 marie.muller@chr-orleans.fr and refer to identifier - NCT02247752  (Study ID # CHRO-2014-02 )

Liver Fibrosis Prevalence in France –France
Cohorts in France will assess the prevalence of fibrosis and specific risks of fibrosis progression in patients with viral hepatitis, NAFLD and ALD. Contact: Thierry Poynard at 00 33  1 42 16 10 22 tpoynard@teaser.fr  or Vlad Ratziu at 00 33 1 42 16 10 02 or vratziu@teaser.fr and refer to identifier - NCT01927133  (Study ID # DRCD2013-01 )

Therapeutic Option for Hepatitis B and C:  A French Cohort –France
Cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will aid with cross-disciplinary and translational research on viral hepatitis and estimate relative effects of treatments and further cost-effectiveness studies. Contact: Dr. Fabrice Carrat at  +33144738458 fabrice.carrat@upmc.fr  or Dr. Celine Dorival at +33144738668 or celine.dorival@upmc.fr  and refer to identifier - NCT01953458  (Study ID # ANRS CO22 HEPATHER, 2011-A01438-33 )

Prevention of Hepatitis B Vertical Transmission by Serovaccination and Tenofovir During Pregnancy –France
The risk of vertical transmission is related to HBV DNA in pregnant women, with around 30% in women with HBV DNA above 1,000,000 IU/mL despite serovaccination of newborns. This study will look at using Tenofovir during the last trimester of pregnancy to reduce the transmission risk.  Contact: Dr. Pierre O Sellier at 00 33  55 149956339 pierre.sellier@lrb.aphp.fr and refer to identifier - NCT02039362  (Study ID # Liver002 )

Real-life Cohort of Patients With CHB Infection –France Constitute a “real-life” cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological, and therapeutic parameters to determine factors associated with the outcome of CHB.  Contact: Dr. Francois Habersetzer at +33(0) 3 69 55 10 09 francois.habersetzer@chru-strasbourg.fr and refer to identifier - NCT01732081  (Study ID # 5452)

PROLIFICA – West African Treatment Cohort for Hepatitis B (WATCH) – Gambia
 This European Commission Funded FP7 project aims to determine whether screening for HBV using a point of care test is feasible and effective. Secondly is to monitor linkage from screening to care. Third is to evaluate cheap noninvasive assessment. Fourth is to determine patients eligible for treatment. Fifth is to establish a TX cohort that can measure adherence to therapy and avoidance of HBV related complications. Contact: Mark R Thursz, MD FRCP at 0207 886 6454 m.thursz@imperial.ac.uk or Maud N Lemoine, MD PhD at 0207 886 6454 m.lemoine@imperial.ac.uk Identifier - NCT02129829  (Study ID # WMDH-P34114)

Assessment of Kidney Function for CHB Patients w/ Nucleos(t)ide Treatment (BONIKA) – Germany
Chronic hepatitis B patients undergoing oral antiviral treatment will be monitored annually for kidney function changes. Contact: Dr. Christoph Sarrazin at +496301 ext 5122, Sarrazin@em.uni-frankfut.de or Dr. Martin Sprinzl at +49613117 ext 0 martin.sprinzl@unimedizin-mainz.de Identifier -NCT02267473  (Study ID # JWGUHMED1-008)

Induction of Fibrosis Regression on Patients with CHB (INFIRE) – Germany
Study will examine whether 12 months treatment with entecavir has an effect on changes of liver stiffness measurement and of hyaluronan measurement in patients with chronic HBV. Contact: Dr. Hermann Wasmuth at +49 241 80 ext 80861 hwasmuth@ukaachen.de Identifier - NCT01341106  (Study ID # CTC-A 11-018m 2010-019884-12, 11-018)

Peg-Interferon ADDed to Ongoing Nucleos(t)ide Based Treatment in Patients W/ CHB to Induce Decrease in HBsAg– Germany
Randomized, open-label phase IIb trial assessing effect of pegysys once weekly for 48 weeks added to ongoing nuclos(t)ide tx in patients with HBe negative CHB. Contact: Dr. Peter R Galle  at +49 6131 17  ext 7275 peter.galle@unimedizin-mainz.de or Dr. Annette Grambihler at +49 6131 17 ext 6075 annette.grambihler@unimedizin-mainz.de  and refer to identifier - NCT01524679  (Study ID #ML 27787)

Patients With CHB and Low Viremia Not Receiving Antiviral Therapy– Germany
An observational long-term study to evaluate demographic, clinical, histological, biochemical, and virological parameters of CHB patients with low viremia, not requiring antiviral therapy.  Contact: Dr. Christoph Sarrazin at +496301 ext 5122 sarrazin@em.uni-frankfurt.de  and refer to identifier - NCT01090531  (Study ID # JWGUHMED1-002)

Efficacy of TDF Switch Therapy in CHB Patients with Incomplete Response to Entecavir – Hong Kong
Randomized, controlled study to evaluate the efficacy of tenofovir switch therapy in patients with incomplete virologic response to entecavir treatment. Contact: Angel ML Chim, MSc at +852 2632 4205 angelchim@cuhk.edu.hk  and refer to identifier - NCT01918631  (Study ID # TDF-ETV-RCT studyA)

Effect of Telbivudine on Renal Function and Proteinuria in Patients with CHB & Renal Disease – Hong Kong
Multicenter, randomized, double-blind, placebo-controlled, dose escalation study to determine the depth and duration of HBsAg reduction after a single intravenous dose of ARC-520 in combination with entecavir in CHB patients. Contact: Dr.Henry LY Chan at (852)2632-2211 hlychan@cuhk.edu.hk or Dr. Angel ML Chim at (852)2632-4205 angelchim@cuhk.edu.hk and refer to identifier - NCT02065336  (Study ID # Telbivudine for CKD)

Study of ARC-520 in Patients with Chronic Hepatitis B – Hong Kong
Multicenter, randomized, double-blind, placebo-controlled, dose escalation study to determine the depth and duration of HBsAg reduction after a single intravenous dose of ARC-520 in combination with entecavir in CHB patients. Contact: Ivy Liu at +886 2 7706 6239 Ivy.Liu@iconplc.com  or Diamond Martin at +1 626 696 4704 dmartin@arrowres.com and refer to identifier - NCT02065336  (Study ID # Heparc-2001)

48-Week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of CHB Patients with HBeAg Serconversion on NU Therapy – Hong Kong
Multicenter, single-arm, open-label on virologicial response of chronic HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on nucleot(s)ide analog treatment and to investigate the sustained response. Contact: Angel ML Chim, MSc at +852 2632 4205 angelchim@cuhk.edu.hk  and refer to identifier - NCT02068365  (Study ID # ML28486)

Tenofovir Pulse and Peg Interferon Alpha2b in HBeAg (+) Patients with Normal ALT – India
Selected patients will be given Tenofovir, monitored and stopped to determine continuation in the trial based on defined criteria to include either the addition of PEG INF + TDF or TDF alone.  Contact: Dr. Sumeet Kainth at +91-46300000 Refer to identifier - NCT02454764 (Study ID #ILBS-HBV-001)

Sonazoid Enhanced Liver Cancer Trial For Early Detection– Japan
Use of contrast enhanced ultrasound (US) using Sonazoid vs. conventional B-mode US for early HCC detection.  Contact: Masatoshi Kudo at +81 72-366-0221 ext. 3149 or m-kudo@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp and refer to identifier – NCT00822991 (Study ID# JLOG08001, UMIN000001612)

Compare Continuing Lamivudine+Adefovir vs Switching to Entecavir+Adefovir in LAM-Resistant CHB– Korea
Compare efficacy and safety continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant CHB with suboptimal response to Lamivudine plus Adefovir or Adefovoir. Contact: Danbi Lee at leighdb@hanmail.net  or call 822-3010-3907 and refer to identifier – NCT02482272  (Study ID # ENTADE)

Therapeutic Vaccination with Intensified Schedule Plus Pegasys Dual Therapy on CHB Infection– Korea
Compare efficacy and safety of therapeutic vaccination with intensified schedule plus Pegylated Interferon dual therapy on seroclearance of HBsAg in Patients with complete virological response induced by Entecavir. Contact: Dr. Yoon Jun Kim at yoonjun@snu.ac.kr or call 82 2 745 1721 or Dr. Yun Bin Lee Dr. Jeong-Hoon Lee pindra@empas.com  and refer to identifier – NCT02097004  (Study ID # E+VIP)

Association Insulin Resistance and Hepatic Fibrosis in CHB and NAFLD– Korea
The aim is to investigate the relationship between insulin resistance, hepatic steatosis and fibrosis in patients with chronic hepatitis B. Contact: Dr. Won Kim at drwon1@snu.ac.kr  or call 8228702233 or Dr. Saekyung Joo joo.sammy@gmail.com 821089619285 and refer to identifier – NCT02031913  (Study ID # HBV_FL)

Phase 3 Study of Besifovir– Korea
Prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected after 48 weeks of Besifovir, or Tenofovir as a control drug to CHB patients. Contact: Se-Eun Kim, Master at trpv1@ildong.com  or call 82(0) 526-3518 or Gayou Hong, Bechelor gyhong@ildong.com 82(0)2 526 3519 and refer to identifier – NCT01937806  (Study ID # ID_BVCL011)

Switching to Tenofovir vs Continuing Entecavir in CHB Patients w/ Partial Virologic Response During Entecavir TX (STEEP) – Korea
Compare the efficacy of switching to tenofovir with continuing entecavir in chronic HBV patients who show partial virologic response to entecavir. Contact: Dr. Hyung Joon Yim at gudwns21@medimail.co.kr  or call 82-31-412-5583 or Dr. Sang Jun Suh mothpickle@naver.com 82-31-412-4926 and refer to identifier – NCT01711567  (Study ID # STEEP study)

HBsAg Related Response Guided Therapy (S-RGT) – Korea
Compare Pegasys RGT overall response (ex. HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72, and to track the change in HBsAg titers. Contact: Kwansik Lee, Professor  at +82-11-9636-9935 or leeks519@yuhs.ac and refer to identifier – NCT01456312 (Study ID #ML25588)

Observational Cohort Study for Durability of antiviral TX in CHB Patients – Korea
Investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guidelines by Asia Pacific Assn. for Study of the Liver (APASL) in Korea. Contact: Dr. Hana Park at PHN223@yuhs.ac or call 02-2228-1931 and refer to identifier – NCT01533051  (Study ID # Quit Anti-viral therapy)

PEG-Interferon Alfa-2a Add-On Study in HBeAg Neg CHB (PAS) – Netherlands
Investigate if addition of PEG-IFN alfa-2a in HBeAg (-) chronic hepatitis B patients who are pretreated with nucleos(t)ide analogs enhances the HBsAg decline. Contact:  Dr. H.L.A Janssen at +14166035800 ext 2776 harry.janssen@uhn.ca or Dr. M.J.H. Van Campenhout at +31107034513 or m.vancampenhout@erasmusmc.nl and refer to identifier - NCT01373684  (Study ID # HBV 11-01)

Safety and Efficacy of NVR 3-778 – New Zealand
Assess dose-related safety and PK of NVR 3-778, first in healthy volunteers and subsequently in patients with chronic HBV. Contact Sandy Liaw at sliaw@noviratherapeutics.com and refer to identifier - NCT02112799 (Study ID # NVR3-778-101)

Comparing Entecavir and Tenofovir in Patients with Decompensated Cirrhosis – Pakistan
Investigators aim to compare safety, efficacy and virological response in patients with HBV decompensated cirrhosis. Contact: Dr. Mohammad Sadik Memon, Fcps gastro at 022-232593 or Sadikmemon@gmail.com or Madiha Zaki, MSC gastro at 022-232593, Madiyaah@gmail.com and refer to identifier – NCT02238860 (Study ID # AIMS-hep B-123)

PROLIFICA – West African Treatment Cohort for Hepatitis B (WATCH) – Senegal  This European Commission Funded FP7 project aims to determine whether screening for HBV using a point of care test is feasible and effective. Secondly is to monitor linkage from screening to care. Third is to evaluate cheap noninvasive assessment. Fourth is to determine patients eligible for treatment. Fifth is to establish a TX cohort that can measure adherence to therapy and avoidance of HBV related complications. Contact: Mark R Thursz, MD FRCP at 0207 886 6454 m.thursz@imperial.ac.uk or Maud N Lemoine, MD PhD at 0207 886 6454 m.lemoine@imperial.ac.uk Identifier - NCT02129829  (Study ID # WMDH-P34114)

Study in Patients with CHB Receiving Therapy w/ PEGASYS – Serbia
Open-label, multicenter, national observational study to investigate the effectiveness of Peginterferon alfa-2a 40kD in patients with chronic HBV. Contact: www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com and refer to Study ID # ML229062 identifier – NCT02201407  (Study ID # ML29062)

Efficacy of Switching or Adding Peginterferon in CHB Patients on Long Term Antivirals (SWAP)  – Singapore
Evaluate whether switching or adding peginterferon compared to continuing antiviral is a more efficacious strategy. Contact: Dr. Seng Gee Lim at mdclimsg@nus.edu.sg and refer to identifier – NCT01928511  (Study ID # MK4031-398 CIRG12may075)

HBV Vaccine in Consolidation of NA Therapy – Taiwan
Determine if patient responds to the HBV vaccine when HBV DNA is suppressed during entecavir or tenofovir therapy, which may decrease HBV relapse rate after completed therapy. Contact: Dr. Dar-In Tai at 886-33281200 ext 8107 tai48978@cgmh.org.tw or Dr. Wen-Juei Jeng at886-33281200 ext 8107 rachel.jeng@gmail.com and refer to identifier – NCT02505009  (Study ID # 104-3167C)

Study for Consolidation Period of CHB – Taiwan
Clarify issue of adequate duration of consolidation period of CHB with Tenofovir treatment to strike balance between durable HBeAg seroconversion and avoiding long-term serological or virological recurrence. Contact: Chunhsiang Wang, Master at chunhsiang_wang@yahoo.com.tw and refer to identifier – NCT01732354  (Study ID # IX-US-174-0206)

Lamivudine Extending Therapy in CHB Patients After 3 yr Antiviral Agents – Taiwan
Study will evaluate the rate of HBV DNA recurrence following stopping antiviral treatment, along with associated predictive factors. Contact: Wan-Long Chuang at Waloch@kmu.edu.tw and refer to identifier – NCT02337127  (Study ID # KMUH-IRB-20110187)

TDF vs LAM for Patients with CHB with Severe Acute Exacerbation (HBSAE) – Taiwan
Evaluate the use of tenofovir versus lamivudine for patients with chronic HBV experiencing a severe acute exacerbation, and which is most effective. Contact: Dr. Wei-Lun Tsai at 886-7-3422121 ext 2075 or tsaiwl@yahoo.com.tw, or Dr. Hoi-Hung Chnan 886-7-3422121 ext 2074 hhchan@vghks.gov.tw, and refer to identifier – NCT01848743  (Study ID # Gilead IN-US-174-0190)

Pegasys Plus Entecavir vs. Entecavir vs. Pegasys HBeAg (-) CHB – Taiwan
Evaluate combination therapy of Pegasys followed by entecavir monotherapy versus Entecavir monotherapy or Pegasys monotherapy for HBeAg negative, chronic HBV patients. Contact: Dr. Pei-Jer Chen at 886-2-231-23456 ext 67072 or peijerchen@ntu.edu.tw, or Chun-Jer Liu 886-2-23-123456 ext 67503 cjliu@ntu.edu.tw , and refer to identifier – NCT01925820  (Study ID # 201205003MPC)

Comparison Between Lamivudine and Entecavir Treatment in Patients (NUC115132) –Taiwan
Prospective, observational, open-label, 2-arm parallel, multi-center study where patients with HBV associated severe acute exacerbation for whom treatment with NRTI (such as lamivudine and entecavir) are medically recommended, enrolled and followed. Contact: Dr. Sheng-Shun Yang +886-4-23592525 ext 3309 or email yansh@vghtc.gov.tw or Dr. Teng-Yu Lee at +866-4-23592525 ext 3301 or tylee@vghtc.gov.tw and refer to identifier NCT01627223 (Study ID # NUC115132)

Tenofovir in Chronic Hepatitis B With Mild ALT Elevation –Taiwan
Clarify whether CHB patients with high viral load will benefit from oral anti-viral therapy despite only mildly elevated serum liver enzymes. Contact: Dr. Jaw-Town Lin +886-2-23123456 ext 62246 or email jawtown@ntu.edu.tw  or Dr. Yao-Chun Hsu at +866-7-6150011 ext 2980 or gatsbyhsu@yahoo.com.tw and refer to identifier NCT01522625 (Study ID # EMRP36100N)

Switch to Tenofovir vs. Continue LAM/ADV TX in LAM-Resistant CHB Patients –Taiwan
Study to evaluate the efficacy of switching to TDF monotherapy from LAM/ADV combo in patients with LAM-resistance in chronic HBV. Contact: Dr. Yi-Hsiang Huang +886-2-28712121 ext 3055 or email yhhuang@vghtpe.gov.tw and refer to identifier NCT01491295 (Study ID # IN-IS-174-0194)

Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B (iTAP) –Thailand
Pregnant women who are HBV infected will receive tenofovir or placebo during the last trimester of pregnancy and 2 months postpartum and perinatal transmission will be compared. Contact Dr. Gonzague Jourdain at  +66818830065 Gonzague.Jourdain@ird.fr or Dr. Nicole Ngo-Giang-Huong at +6625347306 Nicole.Ngo-Giang-Huong@ird.fr and refer to identifier NCT01745822  (Study ID # U01HD071889)

Phase I Safety and Immunogen –United Kingdom
Evaluate safety and efficacy of FP-02.2, a new therapeutic HBV vaccine administered as an add-on therapy to entecavir or tenofovir. Contact: Dr. James Francis +44(0)2076914908 jfrancis@vaxin.com and refer to identifier NCT02496897  (Study ID #FP02.2_CS_01 Clinic)

Tenofovir, Herbal Medicines, Vitamin C Treatment of HBeAg (+)/(-) CHB –Vietnam
Herbal medicines combined with vitamin C plus tenofovir in treatment of acute and chronic HBeAg positive or negative HBV. Contact: Nguyen Thi Trieu  (84)0903640722 trieunguyenthi@ymail.com or Tran Minh Dudc (84)0937244572 trieu.nguyenthi@yahoo.com.vn and refer to identifier NCT01198860  (Study ID # HBsAg 07-10-Private Clinic)

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HBV CO-INFECTION TRIALS

*CHB=Chronic hepatitis B

Treatment of Chronic Delta Hepatitis with Lonafarnib and Ritonavir – U.S. only
Determine the safety and efficacy of Lonafarnib and Ritonavir for the treatment of patients with hepatitis D. Contact: Nancy Fryzek at nancy.fryzek@nih.gov Refer to identifier NCT02511431 (Study ID # 150170, 15-DK-0170)

HBV-HIV Coinfection Research Network – U.S. only
HBV-HIV research network will address important questions and impact the science and health of those that are HBV-HIV coinfected. Contact: Richard Sterling, MD, MSc at rksterli@vcu.edu  Refer to identifier NCT01924455 (Study ID # DK094818)

Long-term Study of Liver Disease in Patients with HBV and/or HCV with or w/out HIV – U.S. only
Study to understand how these viruses affect the immune system over the long-term. Annual visit with researcher, but patient must have a primary care doctor. Contact: Rachel E Newman, RN 202-857-5219, newmanr2@mail.nih.gov or Colleen M Hadigan, MD at 301-594-5754 hadiganc@mail.nih.gov. Refer to identifier - NCT01350648 (Study ID # 110152, 11-CC-0152)

Innate Immunity in HIV Positive Patients co-Infected with HCV or HBV –Australia
Data from this study will provide the first information on how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy. Contact: Jennifer Audsley, PhD (Monash University) at jennifer.audsley@med.monash.edu.au (Refer to identifier -NCT00662194 (Study ID # ALF-55/08)

Hepatitis Delta International Network –International only
Multicenter, observational study will build a registry of HDV patients around the world and collect clinical information. Contact: Dr. Heiner Wedemeyer at Wedemeyer.Heiner@mh-hannover.de or Dr. Svenja Hardtke at Hardtke.Svenja@mh-hannover.de and refer to identifier NCT02375906 (Study ID # HepNet-HDIN)

Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa –Zambia only
Establish a cohort of patients starting antiviretroviral therapy with chronic HBV and study the effect of CHB on HIV and liver related outcomes according to the ART regimen and site. Contact: Dr. Michael Vinikoor at 260 966921285 or Michael.vinikoor@cidrz.org  to identifier NCT02060162 (Study ID # 12-2568)

Hepatic Safety of Currently Used Antiretroviral Regimens in Patients w/CHB –Spain only
Compare liver toxicity in HIV infected patients w/ CHB and/or CHC, who start a new antiretroviral therapy drug regimen, as well as the influence of the degree of existing liver fibrosis on the incidence of liver toxicity. Contact: Karin Neukam, PhD at 0034955015871 karin.neukam@gmail.com or Jose A Mira-Escarti, MD at 0034955015684 miraescarti@yahoo.es  Refer to identifier NCT01908660 (Study ID # SEG-HEP-2007)

Mother-to-Child Hepatitis D Transmission  –France only
Observational cohort to gather data on vertical transmission of HDV. Contact: Dr. Pierre Sellier at 00 33 149956339 pierre.sellier@lrb.aphp.fr Refer to identifier NCT02044055 (Study ID # Liver004)

Safety Study of Tenofovir-containing Drug Regimen for Prevention of Mother to Child Transmission of HIV and HBV –China only
Compare regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO recommended regimen of zidovudine/lamivudine/lopinavir-ritonavir during 2nd & 3rd trimesters in HIV/HBV coinfected pregnant women. Contact: Sascha Ellington, MSPH 770-488-6037 or sellington@cdc.gov and refer to identifier NCT01125696 (Study ID # CDC 5877)

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PEDIATRIC HBV CLINICAL TRIALS

*CHB=Chronic hepatitis B

Non-invasive Biomarkers of Fibrosis in Pediatric Viral Hepatitis –U.S. only
This study is being conducted to develop new techniques for early diagnosis of liver disease. These include Shearwave Elastography (SWE) ultrasound and blood biomarkers. Contact:  Jameisha Brown, BS at 832-824-3813, Jameisha.brown@bcm.edu or Dr. Daniel H Leung at dhleung@texaschildrens.org , 832-822-3606 and refer to identifier – NCT01988753 (Study ID # H-30472)

Pegasys in Combination with Lamivudine in Children with HBeAg Positive CHB in the Immune Tolerant Phase –U.S. and International
Evaluate the efficacy and safety of a combination of Pegasys plus lamivudine compared with an untreated control group in children with CHB in the immune tolerant phase. Contact:www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com and refer to Study ID # NV25361. Identifier – NCT02263079 (Study ID # NV25361, 2006-000977-31)

Tenofovir DF in Pediatric Patients With Chronic Hepatitis B –U.S. and International
Placebo-controlled study evaluates efficacy, safety and tolerability of tenofovir in patients 2 to < 12 years old with CHB. Contact: Gilead Study Team at
174-0144@gilead.com and refer to identifier – NCT01651403 (Study ID # GS-US-174-0144)

Tenofovir in Adolescents with CHB –International only
Characterize the long-term bone safety profile of tenofovir DF in CHB infected adolescents 12 <18 years of age. Contact: Gilead Study Team at GS-EU-174-1403@gilead.com and refer to

Telbivudine in Children and Adolescents w/ Compensated CHB –U.S. and International
Study to assess the efficacy and safety, tolerability and pharmacokinetics of telbivudine in compensated pediatric patients aged 2 to <18. Contact:  Novartis Pharmaceuticals at 1-888-669-6682 and refer to identifier – NCT02058108 (Study ID # CLDT600A2306)

Study of Pegysys vs. Untreated Control in Children With HBeAg+ CHB – U.S. and International.
Evaluate safety and effectiveness of Pegysys vs. untreated control in kids age 3 to <18 yrs at baseline with HBeAg+ CHB. Assignments will be based on fibrosis/cirrhosis status. Contact:www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com and refer to Study ID # YV25718. Identifier – NCT01519960 (Study ID # YV25718, 2011-002732-70)

Pediatric Hepatitis B Research Network Study (HBRN) – U.S. and Canada
An NIH-funded study for children between 6 months and < 18 yrs. with HBV infection in a prospective cohort to identify predictors of disease activation and progression. Contact:  Refer to contacts at individual locations by identifier – NCT01263600 (Study ID # DK082864Pediatric, U01DK082864.) Please click for HBRN details for parents and details for pediatric providers.

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HBV AND LIVER TRANSPLANTATION CLINICAL TRIALS

*CHB=Chronic hepatitis B

GC1102 Recombinant Hepatitis B Immunoglobulin in HBV-related Liver Transplants -Korea
Proof of concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B following liver transplantation, and a dose finding study to determine optimal dose. Contact: Eun-Gi Cho at 82-(0)-31-260-9039, ceg@greencross.com or HyeJung Yang 82-(0)-70-4335-4548 hjyang@symyoo.com and refer to identifier – NCT02304315 (Study ID # GC1102_P2)

IV Hepabig Injection for Prevention of Hepatitis B Relapse After Liver Transplantation -Korea
Exploratory trial to evaluate the pharmacokinetic characteristics of IV Hepabig injection following liver transplantation to prevent HBV relapse. Contact: Dr. Dong Gu Kim at +82-2258-1158, kimdg@catholic.ac.kr and refer to identifier – NCT02125071 (Study ID # I.V. Hepabig injection_IIT)

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HBV AND LIVER CANCER (or HEPATOCELLUAR CARCINOMA, HCC – Section not complete at this time)

*CHB=Chronic hepatitis B

Sorafenib + mFOLFOX for Hepatocellular Carcinoma (HCC) – U.S. only 
In this study, sorafenib,the standard, is being combined with modified FOLFOX. Contact: Daniel Harris at 617-726-8478 and refer to identifier - NCT01775501 (Study ID#: 12-218).

Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area – U.S. only
Patients between the age of 18 & 90 who have been diagnosed with HCC or have a high risk of developing HCC due to HBV, HCV, fatty liver disease, etc. Contact: Dr. Dean L. Mann at 410-328-5512, dmann001@umaryland.edu or Dr. Xin Wang at 301-496-2099 or xw3u@nih.gov and refer to identifier – NCT00913757 (Study ID # 999909149, 09-C-N149)

Multiple Antigen Specific Cell Therapy (MASCT) for HCC Patients After Radical Resection or Radio Frequency Ablation – China
To prove the efficacy and safety of MASCT group is superior to non-treatment group in patients undergone curative resection (RFA or operation) for hepatocellular carcinoma. Contact: Ping Chen, Master at 00860755-86964231 or chenping@thyx.com and refer to identifier – NCT02026362 (Study ID # SYZ Cell Therapy Co.)

Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery – China
Sustained CHB virus inflammation is a major cause of liver cancer occurrence and development. Antiviral treatment can block persistent infection. Aspirin can limit liver cell necrosis and inflammation and can inhibit metastasis.  Contact: Dr. Zheng-Gang Ren at 0086-021-64041990 ext 2149, ren.zhenggang@zs-hospital.sh.cn or Dr. Lan Zhang 0086-021-64041990 ext 2971 zhang.lan@zs-hospital.sh.cn and refer to identifier – NCT01936233) (Study ID # LC-ASPIRIN, ASPIRIN-13-08)

TACE and Adefovir Compared with Transcatheter Arterial Chemoembolization (TACE) Alone for HBV Related Unresectable HCC  –China 
Influence of TACE plus adefovir vs. TACE alone on those CHB patients with unresectable HCC. Contact: Dr. Daoyuan Wang +86 21 6630058 ghealth2008@gmail.com and refer to identifier – NCT00960518 (Study ID # SHDSYY20090725)

A Randomized Study Comparing Lamivudine vs. Adefovir for Prevention of HBV Reactivation in HBsAg+ Patients on Chemo  –Hong Kong
Open label study for HBsAg (+) patients undergoing chemotherapy to receive lamivudine or adefovir during TX. Contact: Dr. Chee-Kin Hui at 852-2818 4300 ckh23@hku.hk and refer to identifier – NCT00489151 (Study ID # UW 04-315 T/637, HARECCTR0500002)

Hypofractionated Proton Beam Radiotherapy for HCC – Korea
Phase II study to evaluate effectiveness of hypofractionated proton Beam therapy for HCC patients in HBV endemic areas.  Contact: Dr. Tae Hyun Kim at +82-31-920-1725 or k2onco@ncc.re.kr and refer to identifier – NCT01643824 (Study ID # 200906051R)

Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Evaluation Liver Functional Status & TX Efficacy in Patients with HCC After Locoregional Therapy – Taiwan
Recruiting patients referred for TACE w/ newly diagnosed, unresectable HCC or tumor reoccurrence and patients treated with RFA as a control group. Contact: Dr. Tiffany Ting-Fany Shih at 886-2-23123456 ext. 65568 or ttfshih@ntu.edu.tw and refer to identifier – NCT01281683 (Study ID # 201010059R)

Dose Escalation Trial of Radiation Therapy (RT) for HCC – Taiwan
Determine max. tolerated dose of RT, and evaluate tumor control, patterns of failure and survival for those HBV carriers with HCC.  Contact: Dr. Jason Chia-Hsien Cheng at 886-2-23123456 ext. 66696 or jasoncheng@ntu.edu.tw and refer to identifier – NCT00960167 (Study ID # 200906051R)

TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma – China only
Determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced HCC not amenable to surgery or local ablative therapy. Contact: Dr. Ming Shi at 86-2087343582 ext 86-2087343582 shiming@mail.sysu.edu.cn or Dr. Rong Ping Guo 86-2087343117 ext 86-2087343117 guorongp@mail.sysu.edu.cn and refer to identifier - NCT01869088 (Study ID # HCC-120402)

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HBV REACTIVATION AND LYMPHOMA

*CHB=Chronic hepatitis B

Abatacept vs Placebo in RA Patients w/ Hepatitis B on Entecavir Background – U.S. only
Purpose is to investigate whether the combination of abatacept along with entecavir is safe and effective in treating symptoms of Rheumatoid Arthritis. Contact: Bal-Ian Yen at 310-206-4112 or byen@mednet.ucla.edu or Gabriel Valdivia at 310-794-9504 or gvaldivia@mednet.ucla.edu and refer to identifier – NCT02053727 (Study ID # IM101329, 13-001279)

Entecavir vs. Lamivudine for Preventing the Risk of HBV Reactivation in NHL – China only
Prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B reactivation in patients with non-Hodgkin Lymphoma on CHOP/R-CHOP. Contact: Dr. Ye Guo +86 21 64175590 ext 8906 pattrick_guo@msn.com and refer to identifier – NCT01914744 (Study ID # LMTG 13-03)

Prophylactic Use of Entecavir for HBsAg (+) Lymphoma Patients with Rituximab based Immunochemotherapy – China only
Identify the effect of prophylactic entecavir in HBsAg positive lymphoma patients treated with rituximab-based immunochemotherapy and or chemotherapy.    Contact: Jun Zhu at zj@bjcancer.org or Yuqin Song at songyuqin622@sina.com and refer to identifier – NCT01768195 (Study ID # PKU-2012111304)

Prophylactic Use of Entecavir for HBsAg (-)/HBcAb (+)/Hepatitis B Virus DNA (-) with Lymphoma – China only
Identify the effect of prophylactic entecavir in HBsAg negative/HBcAb positive/hepatitis B virus DNA negative patients with lymphoma.  Contact: Jun Zhu at zj@bjcancer.org or Yuqin Song at songyuqin622@sina.com and refer to identifier – – NCT01765231 (Study ID # PKU-2012111305)

Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: ENT vs. LAM – Korea only
Compare the effect of entecavir (ENT) versus lamivudine (LAM) to prove the superiority of entecavir over lamivudine for the prevention of reactivation of HBV in HBsAg positive patients undergoing cytotoxic chemotherapy. Contact: Dr. Sook-Hyang Jeong +82 31 787-7034 jsh@snubh.org and refer to identifier – NCT01580202 (Study ID # Al463-246)

HBV REACTIVATION WITH OTHER AGENTS

*CHB=Chronic hepatitis B

Abatacept vs Placebo in RA Patients w/ Hepatitis B on Entecavir Background – U.S. only
Purpose is to investigate whether the combination of abatacept along with entecavir is safe and effective in treating symptoms of Rheumatoid Arthritis. Contact: Bal-Ian Yen at 310-206-4112 or byen@mednet.ucla.edu or Gabriel Valdivia at 310-794-9504 or gvaldivia@mednet.ucla.edu and refer to identifier – NCT02053727 (Study ID # IM101329, 13-001279)

Tenofovir to Prevent HBV Reactivation– Canada only
Determine effectiveness of preemptive tenofovir therapy in preventing reactivation of hepatitis B in patients receiving rituximab-based chemotherapy for Non-Hodgkin’s Lymphoma as compared to patients receiving tenofvir as needed. Contact: Dr. Jordan Feld at 416-603-5914 ext 2684 Jordan.feld@uhn.ca or Victor Lo at 416-603-5839  victor.lo@uhn.ca and refer to identifier – NCT02186574 (Study ID # JF62014)

Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy – U.S. only
Goal is to learn about testing patients for viral infections prior to chemotherapy. Contact: Dr. Jessica P. Hwang at 713-745-4516 and refer to identifier – NCT01970254 (Study ID # 2012-0961, 1R21CA147202-01A1)

Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease – Hong Kong
Determine the prevalence of HBV infection in patients with IBD and rheumatologic disease and to assess the impact of immunosuppressive therapy on viral load and clinical course of IBD patients. Contact: Siew Chien Ng at +852 2632 1519 siewchienng@cuhk.edu.hk  and refer to identifier - NCT02128503  (Study ID # IBD-RA HBV)

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Page last modified September 13, 2015


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