Adults (International)

*CHB=Chronic hepatitis B

For trials listed as "International" or "International Only," click on the NCT identification number for a complete list of participating countries.

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)

Evaluation of Oral JNJ-56136379 Safety, tolerability, Pharmacokinetics With Dosing Regimens With CHBInternational
Safety, tolerability pharmacokinetics with single ascending doses, one multiple dose and multiple doses in patients with chronic hepatitis B. Contact: See trial and link to review criteria for trial. For questions contact JNJ.CT@sylogent.com and and refer to identifier - NCT02662712 (Study ID # CR108092 56136379HPB1001 2015-003724-30)

Safety and Tolerability of TG1050: Dose Finding Study –  International only
Double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients currently being treated for CHB with either tenofovir (TDF) or entecavir antivirals for at least two years, with a well controlled infection. 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- NCT02428400 (Study ID# TG1050.02)

ARB-001467 in Subjects with CHB Receiving NA Therapy –  International  
This study is a single-blind, randomized, placebo-controlled, Phase 2a study evaluating the safety, antiviral activity and pharmacokinetics following multiple doses of intravenous ARB-001467. Contact: Dr. Patricia Mendez at +1-604-677-0248 pmendez@arbutusbio.com or Heather Kato, MAppSc at +1-604-419-3209 hkato@arbutusbio.com and refer to identifier- NCT02631096 (Study ID# ARB-001467-002)

Study of Treatment with RO7020322 in Virologically Suppressed Participants with CHBInternational 

Randomized, multicenter, partially double-blind, placebo, single and multiple ascending dose adaptive parallel study to investigate the safety, tolerability and pharmacokinetics of RO7020322 following oral administration in healthy participants and chronic hepatitis patients. Contact: Reference Study ID # BP29948 at www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com. Identifier – NCT02604355 (Study ID # BP29948)

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 or Andrew Pelesko, BS at 412-383-9584 HBRNDCC@edc.pitt.edu and refer to identifier -NCT01263587 (Study ID # DK082864, U01DK082864)

Clinical Performance Evaluation of DxN HBV Assay – U.S. and Canada

The DxN Hepatitis B Virus (HBV) assay (test) is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population. Contact Lori Lofaro, MSHS, at 760-438-6574 or email lrlofaro@beckman.com and refer to identifier NCT03123159.

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 AssiaBelblidia 514-890-8000 ext 34369 at assia.belblidia.chum@ssss.gouv.qc.ca and refer to identifier -NCT02044523 (Study ID # CE12.062)

Sustained Off-Treatment Response After HBeAg Loss in CHB Treated w/ Nucleos(t)ide Analogues (STOP) – Canada
This study examines 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 antiviral 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)

A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (ACHEIVE) – Canada
This Phase 2, open-label,randomized, multiple dose, varied administration regimen study evaluates the safety and efficacy of the drug SB9200 in patients with CHB. Contact Donald Mitchell at 508-689-9737 or dmitchell@springbankpharm.com and refer to identifier NCT02751996 (Study ID SBP-9200-HBV-201).

Determinants of Virological Response After NA Discontinuation in CHB Patients – Australia
Cessation of NA monitored as per protocol for virological response. The goal is indefinite cessation, but therapy will be restarted if necessary. Contact: Gareth Burns, MD at +61309231 3581 Gareth.burns@svha.org.au and refer to identifier -NCT02581033 (Study ID # 032/14 Protocol #:APP106653)

Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort StudyCameroon
The natural history of hepatitis B and treatment response in West Africa are currently poorly understood. In this study, employees of the Cameroon Baptist Convention Health Board (CBCHB) and spouses who are hepatitis B-positive will be monitored and treated following WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens will be frozen for future analysis. Contact Dr. Norah Nyah at norah_ndi@yahoo.com or puisnto@gmail.com and refer to identifier NCT02766933.

A Nationwide Hospital-based Hepatitis B Registry: China Registry of Hepatitis B – China

CR-HepB registry was started in June 30,2012 to collect HBV cases from general hospitals or specialized hospitals for infectious diseases across mainland China. Demographics, diagnosis, laboratory test results, family history and prescriptions were recorded. The main criteria for registration is HBsAg-positivity more than six months, and these patients will receive followed-up visits every three to six months. Contact: Jidong Jia MD, 010 63139816 or email jia_jd@ccmu.edu.cn or youhongliver@ccmu.edu.cn and refer to identifier NCT03108794

The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B – China

While anti-virus drugs such as entecavir and tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, Chinese traditional medications have also showed effectiveness on hepatitis B symptoms such as hypochondriac pain, jaundice and abdominal mass. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine herbal treatment on chronic hepatitis B. Contact: Jianmei Hao, MD, at 86-29-89626651 or email12479088@qq.com and refer to identifier NCT03018821.

Pegylated Interferon (Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy – China

This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal. The HBeAg-negative patients who received antiviral treatment for 2.5 years will be randomly assigned into three groups: One group discontinues antiviral treatment and is followed for 96 weeks; one group discontinues antiviral treatment and receives Peg-IFN alfa-2a 180 μg weekly for 24 weeks and follow up for 72 weeks, and the third group discontinues the antiviral treatment, receives Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks. Contact Jiming Zhang M.D., by email at jmzhang2006@gmail.com and refer to identifier NCT02594293.

New Strategy Study of Functional Cure of CHB – China
Purpose of this study is to optimize HBsAg clearance in CHB patients with sequential treatment of pegylated interferon alphas-2b and NAs. Contact: Dr. Xiang Zhu at +86-20-85252373 0628zhuxiang@163.com and refer to identifier - NCT02605252 (Study ID # 3rd-sysu-hbv-functional cure)

PEG plus NA in NA-Treated HBeAg Positive Patients – China
Prospective, randomized, multicenter, open-label study. After more than 24 weeks of NA treatment, HBeAg (+) CHB patients who achieved HBV DNA < 1000 cp/ml, but HBeAb (-) will be randomized into 2 study arms. Contact: Qing Xie at 86-13651804273 xieqingrh2015@gmail.com and refer to identifier - NCT02474316 (Study ID # HOPE)

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)

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)

Peginterferon Alfa-2b Treatment in HBeAg-positive Chronic Hepatitis B Patients Based on Interferon Gene Mutation and Receptor Detection – China

The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis B patients with hepatitis B e antigen-positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection. Contact: Wenxiong Xu at 8613760783281 or xwx1983@163.com and refer to identifier NCT02973646.

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.comand refer to identifier - NCT02327416 (Study ID # Anchor 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)

“Real-life” Cohort Study on Patients With Chronic HBV Infection in Jiangsu – China
The investigators propose to sponsor an observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection. Contact: Chao Wu, MD, PhD at 86-25-83105890 or email dr.wu@nju.edu.cn and refer to identifier NCT03097952.

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)

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 Liver Fibrosis – China
Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus pegylated interferon (peg-IFN) for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, thyroid function, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy. Contact: Dr. Hong You at 8610-63139019 or youhong30@sina.com and refer to identifier NCT01938781.

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)

Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients – China
Patients who have completed two years of entecavir-based treatment in Regress Study will receive another 5 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at year 3 in patients who have significant fibrosis at second biopsy. CT and endoscopy will be performed at baseline and year 3. Contact: Hong You at 010-63139019 or youhong30@sina.com and refer to identifier NCT02849132.

Off Treatment Durability in CHB with Good Immune Control – China/Hong Kong

Determine how low quantitative HBsAg should be before one can achieve disease control after treatment cessation. Contact: Dr. Wai-Kay Seto at +85222553994 wkseto@hku.hk and refer to identifier - NCT02738554 (Study ID # UW 15-548)

48-Week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of CHB Patients with HBeAgSerconversion on NU Therapy – China/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)

Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma - China
This study establishes a follow-up strategy of CHB for early detection and diagnosis of liver cancer (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for CHT and cirrhotic patients with different risk of HCC. Contact: Zhongzhen SU, Sun Yat-Sen University. Sp9313@126.com 0086-020-85252010 and refer to identifier NCT02817685. (Study ID SYSU2016)

Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients – China
The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2. Contact: Xinxin Zhang at zhangx@shsmu.edu.cn and refer to identifier NCT03013556.

Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients - China
In this study, the HBeAg-negative CHB patients are treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Contact Yao Xie, Beijing Ditan Hospital, at xieyao00120184@sina.com or call 8613501093293 and refer to identifier NCT02387684 (Study ID DTXY007).

Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients - China
In this study, the HBeAg-positive CHB patients are treated with peginterferon alpha 2a(PEG-IFN a-2a) for an extended period to assess response to treatment. Contact Yao Xie, Beijing Ditan Hospital, at xieyao00120184@sina.com or call 8613501093293 and refer to identifier NCT02387463 (Study ID DTXY008).

Efficacy of Peginterferon Alpha 2a Treatment in CHB Patients Treated with Antivirals - China
In this study, researchers investigate if CHB patients treated with antivirals and peginterferon alpha 2a(PEG-IFN a-2a) will be able to stop antiviral treatment if interferon is successful to lowering HBsAg levels. Contact Yao Xie, Beijing Ditan Hospital, at xieyao00120184@sina.com or call 8613501093293 and refer to identifier NCT02362490 (Study ID DTXY004).

Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis B – China
The study observes the therapeutic effects and long-term follow-up after ending anti-HBV therapy with nucleos(t)ide analogs in patients with CHB. Contact Liang Peng at Third Affiliated Hospital, Sun Yat-Sen University at +8613533978874 or pzp33@hotmail.com or Wenxiong Xu at +8613760783281 or xwx1983@163.com and refer to identifier NCT02883647.

Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroconversion After Interferon Therapy -China
In this study, the long-term efficacy of interferon therapy in HBeAg-positive patients who achieved HBeAg seroconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed. Contact Yao Xie at xieyao00120184@sina.com or 8610-8432220 ext 2489 and refer to identifier NCT02412592 (Study ID DTXY009).

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg– China
The purpose of this study is to optimize HBsAg clearance in CHB patients with sequential treatment of pegylated interferon alpha and NAs. Contact: Xiang Zhu at 1386452564 or 0628zhuxiang@163.com and refer to identifier NCT02745704 (Study ID 3rd-SYSU-I-Cure).

Sustained Viral Response in Patients Who Achieved HBsAg Level≤100 IU/ml After Completed Interferon Treatment – China
Patients with CHB who have achieved HBsAg level≤100 IU/ml after completing interferon treatment will be enrolled and observed for 96 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe, and LFTs will be measured every three months to see if HBV DNA remains undetectable and if HBsAg is lost. Contact: Dr. Yao Xie at 8610-84322200 ext 2489 or xieyao@public.nta.net.cn and refer to identifier NCT02348502 (Study ID DTXY003).

Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment – China
In this trial, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up. Contact: Yao Xie at 8610-84322489 or xieyao00120184@sina.com and refer to identifier NCT02365402 (Study ID DTXY006).

A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB Patients -- China
The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients. Contact: Ke Wang + 862085252372 or wangke19821@126.com and refer to identifier NCT01935635 (Study ID 2014ZX10002002-002).

Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment -- China
HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon alpha 2a treatment will either continue on interferon or have entecavir added to their treatment. The efficacies of the combined therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group. Contact YoXie at xieyao00120184@sina.com or 8613501093293 and refer to identifier NCT02368288 (Study ID DTXY005).

A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis (HBV) – China
This study explores the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B. Contact LunGen Lu at 8613381616206 or lungenlu1965@163.com and refer to identifier NCT02499562.

The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B – China
The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment in order to provide references of clinical trial of the next phase. Contact: Maorong Wang at 025-80864021 and refer to identifier: NCT02965859.

Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy (NAs resistance) – China
The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B. All ages are eligible. Contact: Bristol-Myers Squibb at Clinical.Trials@bms.com and refer to identifier NCT02791386.

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg – China
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy, the purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs. Contact: Dr. Xiang Zhu at 13826452564 or 0628zhuxiang@163.com and refer to identifier NCT02838810.

HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients – China
Hepatitis B surface antigen (HBsAg)loss and seroconversion is uncommon in low-replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in low-replicative chronic HBV infection patients with low levels of HBsAg. Contact: Zhi-Liang Gao at 86-20-85252373 or zhilianggao@21cn.com and refer to identifier NCT02908763

HBV Virions Bound Proteins – France
The emergence of liver cancer - hepatocellular carcinoma (HCC) -- has prompted a search for a thorough understanding of its major causative agents, the hepatitis B virus (HBV). Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HBV virions; (ii) define the modalities of their interaction with HBV proteins; (iii) decipher the topology and subcellular localization of their association with HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory results through a blood draw in these experiments will be disclosed and further investigated at the level of structural biology, in collaborative research programs. Contact Fabien Zoulim, PhD, (0)4 72 68 19 70 ext 33 or email Fabien.zoulim@inserm.fr and refer to identifier NCT02798549.

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: Antoine Lebrere at 33 2 38 74 42 01 antoine.lebrere@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 )

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)

Study of Covalently Closed Circular DNA (cccDNA) in Liver Transplant Patients WithB Virus Markers (ECOGREFFE-B) – France
The aim of this study is to validate in the context of liver transplantation, the interest of the cccDNA assay technique developed by INSERM U1052 on liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver through several groups of patients at transplantation (on graft and native liver explant) and after transplantation. Contact: Dr, Fabien Zoulim at 33 4 26 10 93 55 or fabien.zoulim@chu-lyon.fr and refer to trial identifier NCT02602847.

HBV Virions Bound Proteins – France

This project's goals are to set up adequate conditions for robust and reproducible purification of HBV virions in clinical samples, followed by the identification of their HBV-bound host proteins and the characterization of their functions. Proteomics profiling of HBV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HBV particles, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HBV-replicating cells. Contact: Prof. Fabien Zoulim at (0)4 72 68 19 70 ext +33 and Fabien.zoulim@inserm.fr and refer to identifier NCT02798549,

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.deIdentifier -NCT02267473  (Study ID # JWGUHMED1-008)

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)

Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection – Hong Kong
This phase 2 study examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection. Contact: Vincent Lopez at 910 558 2051 or email Vincent.lopez@ppdi.com and refer to identifier NCT02981602.

 

Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus – India
This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months. Contact: Dr. AlbenSigamani at alben.sigamani.dr@nhhospitals.org or 91 8884431444 and refer to identifier - NCT02899130.

To Study the Efficacy of PEG-IFN Alpha in HBeAg-Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy – India
The purpose of the study is to learn about the impact of pegylated interferon on HBeAg-negative people who were treated with tenofovir or entecavir for more than one year. Contact: Karan Kumar, MD, at 01146300000 or email karanbjmc93@gmail.com and refer to identifier NCT03123653.

 

Cost Effective Non Invasive Diagnostic Modalities and Predictive Model for Development and Progression of Fibrosis Among Patients With Hepatitis B, Hepatitis C Infection or Non Alcoholic Fatty Liver Disease – India
Researchers will collect socio-demographic data, clinical data, family history, personal history, medical history, anthropometry, biochemical and radiological data from each patient to conducta cost-effective analysis for various noninvasive tests against using a liver biopsy as a gold standard in predicting fibrosis, both for retrospective and prospective cohorts. After evaluation of baseline biopsy results, the cases with metavir fibrosis score (F0-3) will be followed for a period of 5 years to document incidence of development and progression of fibrosis. Contact: Dr. Ajeet Singh Bhadoria at 91-11-01146300000 ext 16501 or ajeetsinghbhadoria@gmail.com and refer to identifier: NCT02658786.

A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects – Korea and Hong Kong
The development goal for GSK3389404 is the establishment of a finite duration treatment that results in sustained suppression of hepatitis B virus (HBV) replication and viral antigen production due to the restoration of an immune response. This study is a multicenter, randomized double-blind (sponsor un-blinded in Part 1), placebo-controlled study which will evaluate the safety, tolerability, PK, and PD profile of GSK3389404 with increasing doses, along with a placebo controlled group. Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalsupporthd@gsk.com or +44 (0) 20 8990 4466 and refer to identifier: NCT03020745.

Treatment Efficacy and Safety of Tenofovir (TDF) in TX Naïve CHB– Korea
Open label, single arm cohort study to see the efficacy and safety of tenofovir (TDF) in treatment naïve chronic HBV patients. Contact: Dr. Myeong Jun Song at 8242-220-9291 mjsong95@gmail.com and refer to identifier – NCT02533544 (Study ID # IN-US-174-1805)

Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine – Korea
Single center, open label, phase I/IIa study to evaluate safety, tolerability and efficacy of a therapeutic vaccine in oral antiviral drug-treated CHB. Contact: Dr. Kyu-Sung Rim at 82-31-780-5212 ksrimmd@cha.ac.kr Dr. Hana Park at PHN223@cha.ackr or call 82-30-780-4927 and refer to identifier – NCT02693652 (Study ID # CVI-HBV-002-CT 1301)

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)

Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults – Korea
This study will monitor changes in hepatitis B surface antigen (HBsAg) during 12 weeks of treatment with pegylated interferon to determine if HBsAgchange is an indicator of treatment success. Contact: Sang HoonAhn at 82-2-2228-1936 or ahnsh@yuhs.ac and refer to identifier NCT02822547.

A Korean Cohort Study of TDF Rescue Therapy for Difficult-to-treat CHB Patients: a Comparison Between TDF Monotherapy and TDF-based Combination Therapy – Korea
Rescue (tenofovir) TDF monotherapy or TDF-based combination therapy are available in Korea for patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures. However, which is the better has not been evaluated yet. This study evaluates the long-term efficacy and safety of TDF-based rescue therapies in real practice. Contact: Dr. Sang HoonAhn at 82-2-2228-1936 or ahnsh@yuhs.ac and refer to identifier NCT02019966.

A Clinical Trial to Evaluate the Efficacy and Safety of Tenofovir With and Without UDCA in Patients With HBV – Korea
This trial is an exploratory, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of tenofovir with and without Ursodeoxycholic Acid(UDCA) in patients with chronic hepatitis B. Contact Dr. Chang Wook Kim at 82-31-847-2719 or cwkim@catholic.ac.kr and indicate trial identifier NCT02966964.

Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude – Korea
The purpose of this Phase IV study for adults age 19 and older is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab (Cavir). Contact: EunSol Kim at +82-2-410-8747 or snow-white@hanmi.co.kr and refer to identifier NCT02523547 (Study ID HM-CAV-401).

Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet – Korea
A multicenter, randomized, double-blind, Phase III trial to evaluate the efficacy and safety of CKD-390 tablet and Viread® tenofovir tablet in CHB patients. Contact: Kwan Sik Lee at leeks519@yuhs.ac and refer to identifier NCT02805738 (Study ID 163HBV15036).

A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients – Korea
This study is SAD (Single Ascending Dose)/MAD (Multiple Ascending Dose) study to explore the tolerability, safety and pharmacokinetics/pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin) in chronic hepatitis B patients. Contact: Jung-Woo Park at 82-(0)31-260-1905 or pjw0620@greencross.com and refer to identifier NCT02569372.

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, Tolerability, Pharmacokinetics of RO7020322 – New Zealand
Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7020322 in healthy volunteers and patients with chronic HBV. Contact: Email global.rochegenentechtrials@roche.com and refer to the Study ID number BP29948 - NCT02604355 (Study ID # BP29948)

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B – New Zealand
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of two sub-parts which will be used to further refine the dose and dosing regimen. Contact: 888-662-6728 (US and Canada) or email global.rochegenentechtrials@roche.com and refer to NCT03038113.

A Study in Healthy Volunteers and Patients with Chronic Hepatitis B – New Zealand
This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients. Contact: Assembly Biosciences at clinicaltrials@assemblybio.com. Refer to identifier NCT02908191.

A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531 – New Zealand and International
This participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic hepatitis B. Part I will be conducted in two portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include only healthy volunteers. Part II will commence after completion of the MAD portion of Part I and will include only Chronic Hepatitis B (CHB) participants. The trial will eventually recruit in Bulgaria and Hong Kong also. Contact: Hoffmann-La Roche at 888-662-6728 or email global-roche-genentech-trials@gene.com and refer to identifier NCT02956850.

 

Efficacy and Safety of TenofovirAlafenamide (TAF) Versus TenofovirDisoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant – New Zealand
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofoviralafenamide (TAF) versus tenofovirdisoproxil fumarate (TDF)-containing regimens in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant. Contact: Amy Cole at acole@adhb.govt.nz and refer to identifier NCT02862548.

To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B (RC14/055) – Saudi Arabia
To assess whether PEG-INF (Peglyated - interferon) add-on therapy in patients with chronic hepatitis B who have achieved a maintained viral suppression (HBV DNA PCR (polymerase chain reaction) <200 for last 3-6 month) with antivirals can result in increased rate of HBV infection eradication (with HBsAg is undetectable by serological blood testing with or without seroconversion to HBs antibody). Contact: Abduljaleel Alalwan, MD, at 801 111 ext 11622 or email alwana@ngha.med.sa and refer to identifier NCT02982837.

Peg-interferon For Inactive HBV Carriers – Singapore
Chronic hepatitis B carriers (normal liver function and low viral load (< 2 x 10^4 IU/ml) are not recommended to be treated by guidelines as they are at low risk for complications. This study determines the possibility of HBsAg loss in chronic hepatitis B carriers in a randomized, open-label clinical trial comparing no treatment to 24 weeks peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on therapy and matched to an equivalent time point in the control arm. The sample size is 30 patients in each arm. Contact: Seng Gee Lim, FRACP, FRCP, MD, at (65) 67724369 or email mdclimsg@nus.edu.sg and refer to identifier NCT02992704.

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)

Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B (DUAL) -- Singapore
This study compares the effectiveness of tenofovir to a combination of tenofovir plus telbivudine. Contact: Seng Gee Lim at + 65-67724369 or mdclimsg@nus.edu.sg or mdccsyc@nus.edu.sg and refer to identifier NCT02774837 (Study ID 2013/00215).

Prevalence of Hepatitis B in Valles Occidental. Observational Multicentric Study – Spain
The aim of this observational study is to evaluate the prevalence of hepatitis B in Valles Occidental in Spain. Also, it will describe the stage of the disease, and whether participants are under medical treatment or not. Contact: Mireia Miquel, PhD, +34937231010 ext. 2980. Refer to identifier: NCT02548325

Off-therapy Response After Stopping Entecavir or Tenofovir – Taiwan
There is lack of data regarding what happens when tenofovir treatment ends in patients with chronic hepatitis B. The investigators plan to enrolled 400 patients who had received entecavir or tenofovir and stopped treatment.The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with entecavir and tenofovir therapy, and to identify the predictive factors of relapse. Contact: Ming Lun Yeh, MD, 886 73121101 ext 7475 or email minglunyeh@gmail.com and refer to identifier NCT03042481.

The Relationship Between Vitamin D and Hepatitis B Replication – Taiwan
Researchers are studying 300 HBV carriers with inadequate serum vitamin D levels. They will be randomized into two groups: one is supplied with vitamin D and another without as controls. The markers of HBV replication will be compared before and after treatment. Contact: Chia-Chi CC Wang at +886 2 6628 9779 ext. 2315 or email uld8888@tahoo.com.tw and refer to identifier NCT03068767.

Clinical Course Study in CHB After NA Therapy– Taiwan
Recruit CHB patients indicated for stopping NA therapy, and collect clinical and virological data after stopping NA therapy. Prognostic factors will be analyzed.  Contact: Dr. Teng-Yu Lee at +886423592525 ext. 3301 tylee@vghtc.gov.tw  and refer to identifier – NCT02582333  (Study ID # CF15340B)

Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration – Taiwan
The trial studies the effect of adding spirulina platensis, whichcontains numerous nutrients, especially vitamin B and beta-carotene, to the diets of people with hepatitis B to see if it reduces the risk of liver damage and cancer. Contact: Dr. Ming Shun Wu at 886229307930 ext 7923 or mswu@tmu.edu.tw and refer to study identifier NCT02953600.

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)

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)

Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues (HBV) - Taiwan
This study compares besifovir to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of besifovir 150 mg, or tenofovir 300 mg as a control drug in CHB patients. Contact: Junghee Won at 82-2-526-3512 or jh-won@ildong.com or Yoan Park at 82-2-526-3524 or yapark@ildong.com and refer to identifier NCT02792088 (Study ID ID_BVCL012).

Phase 2, Multiple Ascending Dose Proof of Concept Study –Thailand
Study to evaluate the safety and tolerability of multiple doses of CMX157 at increasing dose levels in hepatitis B infected people. Contact: Michael A. Conover 732-902-4000 or email mconover@contravir.com and refer to identifier NCT02710604 (Study ID # CTRV-CMX157-201)

Phase I Safety and Immunogenicity of FB-02.2 in Chronic HBV –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. Bertrand Georges at +44(0)2076914908 bgeorges@altimmune.com and refer to identifier NCT02496897  (Study ID #FP02.2_CS_01 Clinic)

A Study of ALN-HBV in Healthy Adult Volunteers and Non-Cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection – London, United Kingdom
The purpose of this Phase 1/2 study is to determine the safety, tolerability and pharmacokinetics of the drug ALN-HBV in healthy adult volunteers and patients with CHB. Contact Contact: Alnylam Clinical Trials Hotline at 617-575-7400 or 1-866-330-0326 and refer to identifier NCT02826018. (Study ID # ALN-HBV-001)

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

Chronic Hepatitis B Virus in Zambia (HUTCH) – Zambia
The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection and describe treatment and care outcomes. 500 adults will be enrolled and followed for up to five years to assess short- and long-term viral, serologic and liver outcomes such as cirrhosis and liver cancer. Contact: Michael Vinikoor, MD at 260966921285 mjv3@uab.edu. Refer to identifier - NCT03158818.