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 June 7, 2013

U.S. CLINICAL TRIALS

*CHB=Chronic hepatitis B

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 – US 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 marcg@mail.nih.gov.and refer to identifier - NCT01821794 (Study ID # 130091, 13-DK-0091)

Study Evaluating GS-9620 in Virologically Suppressed Subjects With CHB – U.S. only
Double-blind, randomized, placebo controlled dose ranging trial to evaluate aspects of GS-9620 in virologically suppressed subjects with CHB. Contact: Dr. Uri Lopatin at 650-522-5120 Uri.Lopatin@gilead.com or Dr. Benedetta Massetto at 650-522-5075 Benedetta.Massetto@gilead.com Refer to identifier – NCT01590654 (Study ID#GS-US-283-0102)

Study Evaluating GS-9620 in Treatment Naïve Subjects with CHB – U.S. only
Double-blind, randomized, placebo controlled dose ranging trial to evaluate aspects of GS-9620 in treatment naïve patients with CHB. Contact: Dr. Uri Lopatin at 650-522-5120 Uri.Lopatin@gilead.com or Dr. Benedetta Massetto at 650-522-5075 Benedetta.Massetto@gilead.com Refer to identifier - NCT01590641 (Study ID#GS-US-283-0106)

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 marcg@mail.nih.gov. Refer to identifier - NCT01581554 (Study ID#110151, 11-DK-0151)

Combination Entecavir and Peginterferon for HBeAg+ Immune Tolerant Adults With CHB – U.S. only
Evaluate safety and efficacy of short lead-in course of entecavir followed by combination of entecavir plus peginterferon for 40 weeks. Contact: Jennifer Dobberstein,MS 412-624-5555 jad183@pitt.edu. Refer to identifier - NCT01369199 (Study ID # 120071, 12-DK-0071)

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: Elenita Rivera, RN at 301-496-3531 erivera@cc.nih.gov or Dr. Marc Ghany at 301-402-5115 marcg@mail.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: Colleen Kotb, RN 202-857-7652 kotbch@mail.nih.gov or Dr. Shyamasundaran Kottilil 301-435-0936 skottilil@niaid.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@bdg10.niddk.nih.gov. Refer to identifier - NCT00001971 (Study ID # 910214, 91-DK-0214)

Long-term Study on Anti-HBV Effect of Tenofovir (TDF) and Resistance Surveillance in Asian American Adult Patients – U.S. only
Phase IV observational study evaluating antiviral efficacy, safety, tolerability, virological response & mutations based on TDF in HBV infected Asian-Americans. Contact: Dr. C. Pan at cpan11355@yahoo.com or call 718-888-7728 and refer to identifier- NCT01267162 (Study ID # IN-US-174-0156)

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 marcg@mail.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 alone given for 4 years in CHB patients. Contact: Jennifer Dobberstein, MS at 412-624-5555 or jad183@pitt.edu or Ethan Obstarczyk at 412-383-9684 or obstarczyke@edc.pitt.edu and refer to identifier - NCT01369212 (Study ID# DK082864 HBRN Immune Active)

Combination Entecavir & Peginterferon in HBeAg+, Immune Tolerant CHB Adults – U.S. and Canada
Evaluate safety and efficacy of 8 weeks of entecavir followed by combo ENT + PEG for 40 weeks, thereby hoping to gain a higher rate of HBeAg loss and viral suppression. Contact: Jennifer Dobberstein, MS at 412-624-5555 or jad183@pitt.edu and refer to identifier - NCT01369199 (Study ID# DK082864 HBRN IT Adult Trial)

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: Ethan Obstarczyk 412-383-9584 or obstarczyke@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

Dose Ranging Study of pegIFN lambda in HBeAg (+) CHB Patients –U.S. and International
Identify dose of pegIFN that is safe, well tolerated and efficacious for CHB treatment. Contact: For trials within U.S., refer to site phone no. listed. For site info outside U.S. contact BMS at Clinical.Trials@bms.com and refer to identifier-NCT01204762 (Study ID # Al452-005, 2010-020387-38) First line of email MUST contain NCT# & site#.

INTERNATIONAL CLINICAL TRIALS

*CHB=Chronic hepatitis B

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)

Dose Ranging Study of pegIFN lambda in HBeAg (+) CHB Patients – U.S. and International
Identify dose of pegIFN that is safe, well tolerated and efficacious for CHB treatment. Contact: For trials within U.S., refer to site phone no. listed. For site info outside U.S. contact BMS at Clinical.Trials@bms.com. First line of email MUST contain NCT# & Site# Refer to identifier - NCT01204762 (Study ID # Al452-005, 2010-020387-38)

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)

Safety and Efficacy of PEG-Intron vs. PEGASYS in Patient with CHB – Australia only
Compare the safety and efficacy of PEG-intron to that of PEGASYS in participants with CHB who have not been previously treated with interferon. Contact: Dr. Gary Jankelowitz at 61 29795-9500 or toll free at 1-888-577-8839 Refer to identifier – NCT01641926 (Study ID #P08450, MK-4031-376)

Pegylated Interferon and Entecavir Combination in CHB – Bangladesh only
Assess whether the combination of PEG and entecavir offer the best outcome to treatment naïve CHB patients in terms of virological and biochemical response, TX cost, duration and adverse events. Contact: Dr. Mamun Mahtab at +880 171-156-7275 shwapnil@agni.com or Helal Uddin, BSc, DPH at +8801819251514 or bhc@dhaka.net Refer to identifier – NCT01589952 (Study ID # BB1)

Observational Study of Pegasys in HBeAg +/- CHB Patients – Bulgaria only
Observational study will evaluate on-treatment predictors of patients with HBeAg+/- CHB receiving Pegasys treatment for duration of TX plus 24 weeks. Contact: www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (US only) and refer to Study ID # ML25626. Identifier - NCT01667432 (Study ID # ML25626)

Clinical Effects and Cost-effectiveness Analysis of Early Antiviral Therapy on HBV-related Compensated Liver Cirrhosis – China
Investigate clinical effects and cost-effectiveness of two early antiviral strategies (Entecavir or Lamivudine plus Adefovir) on HBV related compensated liver cirrhosis through prospective, open-label, multicenter, nonrandomized study. Contact: Dr. Ji Jia at 86-10-63139816 or jiamd@263.net, or Dr. Hong You at 86-10-63139019 or youhong30@sina.com and refer to identifier - NCT01720238 (Study ID # D12110000039120003)

Efficacy Optimizing Extension Study of CHB Patients with Inadequate Response to NUC Therapy (Dragon-Ex) – China
Study to compare the long-term and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy. Contact: Dr. Jinlin Hou at 86-20-61641941 or jhousmu@yahoo.com.cn, or Jian Sun at 86-20-62787432 or sunjian@fimmu.com and refer to identifier - NCT01829685 (Study ID # MOH-06)

Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV Related Cirrhosis – China
Patients with HBV related cirrhosis will undergo administration of human hUC-MSC via hepatic artery to evaluate safety and efficacy for the patient. Contact: Ying Han at 86-29-84771539 or Hanying@fmmu.edu.cn or Yongquan Shi at 86-29-84771515 shiyquan@fmmu.edu.cn and refer to identifier - NCT01728727 (Study ID # 20120912-3)

Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV Related Liver Cirrhosis – China
Patients with HBV related cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate safety and efficacy for the patient. Contact: Ying Han at 86-29-84771539 or Hanying@fmmu.edu.cn or Yongquan Shi at 86-29-84771515 shiyquan@fmmu.edu.cn and refer to identifier - NCT01728688 (Study ID # 20120912-2)

Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV Related Cirrhosis – China
Patients with HBV related cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate safety and efficacy for the patient. Contact: Ying Han at 86-29-84771539 or Hanying@fmmu.edu.cn or Yongquan Shi at 86-29-84771515 shiyquan@fmmu.edu.cn and refer to identifier - NCT01724697 (Study ID # 20120912-1)

Effectiveness of Nucleos(t)ide Analog Therapy (NUC) Among Naïve CHB Patients – China
Compare effectiveness of Entecavir monotherapy and Lamivudine based therapies among chronic hepatitis B patients who are naïve to NUC at enrollment. Contact: For information please email individual site. First line of email MUST contain NCT# & Site# Refer to identifier - NCT01726439 (Study ID # AI463-952)

Study of Pegasys in Chinese Patients With HBeAg Neg. CHB – China
Evaluate efficacy and safety of Pegasys (peginteferon alfa-2a) in HBeAg neg. CHB Chinese patients. Contact: Reference Study ID # ML28516 at www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) genentechclinicaltrials@druginfo.com. Identifier - NCT01730508 (Study ID # ML28516)

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 and refer to identifier - NCT01679769 (Study ID # 2012-455, 81170386)

Telbivudine Therapy in HBeAg+ Pregnant Women to Prevent Mother to Infant Transmission of HBV – China
Study to determine whether telbivudine among HBsAg+ and HBeAg+ pregnant women during the 3rd trimester, in addition to immunoprophylaxis in infants is more effective than standard immunoprophylaxis in preventing HBV infections in infants. Contact: Dr. Yi-Hua Zhou at +86 25 8330 4616 ext 10373 yzh2006111@yahoo.com or Dr. Yali Hu at +86 25 8330 4616 ext 66808 dtylhu@126.com and refer to identifier – NCT01637844 (Study ID # 2012019)

Tenofovir in Late Pregnancy to Prevent Vertical Transmission of HBV – China
Evaluate tolerability, safety, and efficacy of reduction of HBV vertical transmission rate using Tenofovir, a pregnancy category B medication, on HBeAg+ pregnant women . Contact: Dr. Calvin Pan at +01-7188887728 cpan11355@yahoo.com or Dr. Frank Huang at +86-13533051208 frankhuangyujun@gmail.com and refer to identifier - NCT01488526 (Study ID # IN-US 174-0174)

EFFORT Extension Study (EFFORT-Ex) – China
Prove that long-term efficacy of strategy of TX adjustment at week 24 according to virological response based on ROADMAP is better than the standard care strategy and the evaluation of off-treatment durability of HBeAg seroconversion in patients who discontinued TX due to sustained HBeAg seroconversion and HBV DNA<300 cp/ml over 12 months consolidation TX. Contact: Dr. Jinlin Hou at 86-20-61641941 or jhousmu@yahoo.com.cn, or Jian Sun at 86-20-62787432 or sunjian@fimmu.com and refer to identifier - NCT01529255 (Study ID # MOH-05)

A Two-Year Study of Telbivudine in HBeAg Negative Hepatitis (STEN) – China
ROADMAP strategy provides individualized telbivudine treatment for HBeAg neg CHB patients, where telbivudine is given, but may include adding adefovir based on patient’s response. Contact: Dr. Chao-Shuang Lin at 0086(020)85252110 or linchaoshuang@yahoo.com.cn and refer to identifier - NCT01521975 (Study ID # HBeAg negative Roadmap)

Efficacy and Safety of Dual-Plasmid Hepatitis B Virus DNA Vaccine in CHB – China
Double blind, randomized, placebo controlled trial to study immunotherapeutic effects of EP mediated dual-plasmids HBV vaccine on CHB patients with ALT 2X ULN, with antiviral treatment indicated. Contact: Dr. Fuqiang Yang at 00862087376240 or yangfq23@163.com and refer to identifier - NCT01487876 (Study ID # 2011005SW0101)

HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated – China
Investigate PEG-IFN ability to achieve HBsAg loss/seroconversion in inactive carriers with persistently normal ALT, undetectable DNA and low surface antigen levels. Contact: Dr. Yao Xie at +8610-84322489 or xieyao@public.bta.net.cnand refer to identifier - NCT01471535 (Study ID # DTH-XY002)

Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With CHB Infection– China
Patients are divided into two groups: early and conventional antiviral treatment. 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)

Efficacy Optimizing Research of CHB Patients with Inadequate Response to NUC Therapy – China
Evaluate the efficacy and safety of generic entecavir monotherapy, or in combination with adefovir in patients with inadequate response to NUC. Contact: Dr. Jinlin Hou at 86-20-61641941, jlhousmu@yahoo.com.cn or Dr. Jian Sun at 86-20-62787432, doctorsunjian@163.com and refer to identifier - NCT01341743 (Study ID # MOH-04)

Efficacy and Safety of Telbivudine on Liver Cirrhosis in Patients with CHB – China
Antiviral treatment of CHB patients with liver cirrhosis using telbivudine. Contact: Honghao Zhang at zhanghonghao@medmail.com.cn and refer to identifier - NCT01380951 (Study ID # szwy20110610)

Influence of Hepatic Steatosis on Entecavir in CHB Patients – China
Investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in CHB patients. Contact: Dr. Xi Jin at 0086-571-87266532 or jxfl007@hotmail.com and refer to identifier -NCT01148576 (Study ID # NCTZJU201001)

Early Response to Interferon Combined with Short-Term Nucleoside Analogue Therapy in HBeAg (+) CHB– China
Interferon is used for 12 weeks at which time if HBV DNA is undetectable (<1000 copies/ml), it is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After 3 months if HBV DNA is undetectable, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue. Contact: Dr. Huang Zhanlian at +86 013 58 05 84031 or email zhanlianh@21cn.com Refer to identifier - NCT00860626 (Study ID # interferonshorttermnucleoside)

Resistance to Lamivudine in HBV Egyptian Patients – Egypt
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients. Contact: Professor Mohammed Montasser at +01223363398 mfm1947@gmail.com and refer to identifier – NCT01548820 (Study ID # HBV resistance)

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)

Assess and Monitor of Renal Proximal Tubular Tolerance of Nucleos(t)ide Analogues Using Early Screening Tools in CHB Patients (HBVSECURE) –France
The assessment and monitoring of proximal tubular nephropathy with long-term NA use, using early screening tools - especially for patients on tenofovir. Contact: Dr. Veronique Loustaud-Ratti at 05 55 05 66 84 veronique.loustaud-ratti@unilim.fr and refer to identifier NCT01500265 (Study ID # I10006 HBVSECURE)

Evaluation of Innovative Ultrasonic Techniques for Non-Invasive Diagnosis of Liver Fibrosis in Patients with CHB or CHC (FIBRECHO) –France
Evaluation of the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis. Contact: Dr. Vincent Leroy at EChipon@chu-grenoble.fr and refer to identifier NCT01537965 (Study ID # DCIC 11 03)

Observational Study of Pegasys in HBeAg (+)/(-) CHB– Germany
An observational study to evaluate efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with HBeAg positive or negative CHB. Contact: Reference Study ID # ML25614 www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) genentechclinicaltrials@druginfo.com. Identifier - NCT01734018 (Study ID # ML25614)

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. Marcus Schuchmann at +49 6131 17 ext 7104 marcus.schuchmann@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)

Stopping TDF TX After Long Term Virologic Suppression in HBeAg (-) CHB – Germany
Patients treated with TDF for at least 4 years, achieving and maintaining virologic suppression will be included in this two arm study to monitor for biochemical flares, possibly requiring TDF therapy restart. Contact: Dr. Lothar Gallo at +49(0)89 89 98 90 ext. 18, lothar.gallo@gilead.com, or Dr. Eduardo Martins at +1 (650) 522-5792 eduardo.martins@gilead.com and refer to identifier NCT01320943 (Study ID # GS-EU-174-0160, 2010-021925-12)

Study of FG-3019 in HBV in Subjects with Liver Fibrosis Due to CHB – Hong Kong
Evaluate efficacy of FG-3019 to reverse liver fibrosis in patients with CHB starting Entecavir treatment. Contact: Dr. Katharina Modelska at kmodelska@fibrogen.com or call 415-978-1366 and refer to identifier – NCT01217632 (Study ID # FGCL-3019801)

Randomized Controlled Study of Tenofovir Plus Telbivudine vs. Monotherapy with either drug in HBeAg (-) CHB patients – India
Determine efficacy and safety of combination therapy of tenofovir plus telbivudine vs. monotherapy with either drug. Contact: Dr. Manoj Kumar at +91-11-64659881, manojkumardm@gmail.com , or Dr. Tarandeep Singh at +91-11-64659881, drtarandeep@gmail.com Refer to identifier - NCT01260610 (Study ID # CLDT600AIN05T)

Beneficial Effect of Vitamin D Supplement to PEG IFN or Telbivudine Monotherapy in CHB Patients– Israel
The impact of Vitamin D, an important immune-modulator, has on virologic response of patients undergoing peg or nucleotide analog therapy. Contact: Dr. Assy Nimer at +97246828445 or ASSY.N@ZIV.HEALTH.GOV.IL and refer to identifier - NCT01083251(Study ID #004-10)

Pegasys Added to Nucleos(t)ide Analogue Treatment in HBeAg Neg. CHB Genotype D Showing HBV DNA Suppression – Italy
Evaluate efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue treatment in patients with HBeAg negative CHB with genotype D showing stable HBV DNA suppression. Contact: www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) genentechclinicaltrials@druginfo.com and reference Study ID Number ML28262. Identifier - NCT01706575 (Study ID #ML28262, 2012-0000080-25)

IL28B Polymorphism in HBeAg (-) CHB Patients Treated With Pegasys in ML18253 – Italy
Cross-sectional multicenter study will evaluate IL28B polymorphism in patients with HBeAg neg CHB treated with Pegasys in the predecessor ML18253 study. Contact: www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) genentechclinicaltrials@druginfo.com and reference Study ID Number ML28470. Identifier - NCT01697501 (Study ID #ML28470, 2012-002777-56)

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)

Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease– Japan
Multi-center cross-sectional study using Real-time Tissue Elastography measurements prospectively from HBV/HCV patients presenting for liver biopsy. Contact: Dr. Norihisa Yada at +81 72366-0221 ext. 3525 or yada@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindi.ac.jp and refer to identifier -NCT01360879 (Study ID# JLOG1002)

Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastopgraphy– Japan
Multi-center cohort study using Real-time Tissue Elastography measurements to predict the incidence of HCC and severity of ascites & decompensated cirrhosis in HBV/HCV patients. Contact: Dr. Norihisa Yada at +81 72366-0221 ext. 3525 or yada@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 - NCT01360892(Study ID# JLOG1003)

Comparison of Telbivudine + Adefovir (ADV) with LAM + ADV for the Treatment of Lamivudine Resistant CHB at 52 Weeks (TeSLA)– Korea
Evaluate safety and efficacy of telbivudine plus adefovir compared with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patients at the end of 1 year follow-up. Contact: Dr. Hyung Joon Yim gudwns21@medimail.co.kr at 82-31-412-5583 and refer to identifier – NCT01804387 (Study ID #TeSLA study)

TDF vs LAM+ADV in LAM+ADV Treated LAM-Resistant CHB Patients with Undetectable Virus DNA – Korea
Provide rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in lamivudine plus adefovir treated lamivudine resistant CHB patients with undetectable HBV virus DNA. Contact: Dr. Byoung Kuk Jang at +82-53-250-8024 or jangha106@dsmc.or.kr and refer to identifier – NCT01732367 (Study ID # TDF0001)

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 titres. Contact: Kwansik Lee, Professor at +82-11-9636-9935 or leeks519@yuhs.ac and refer to identifier – NCT01456312 (Study ID #ML25588)

Tenofovir Plus Entecavir vs. Tenofovir in Adefovir-Resistant CHB – Korea
Investigate whether tenofovir monotherapy is effective in inducing complete virologic response compared with tenofovir plus entecavir in CHB patients with genotypic resistance to ADV & partial virologic response to ongoing TX. Contact: Dr. Young-Suk Lim limys@amc.seoul.kr or 82-2-3010-5933 and refer to identifier – NCT01639066 (Study ID #AMC2012-1208)

Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant CHB – Korea
Investigate whether tenofovir monotherapy is as effective as tenofovir plus entecavir in inducing complete virologic response in CHB patients with genotypic resistance to ETV & partial virologic response to ongoing TX. Contact: Dr. Young-Suk Lim limys@amc.seoul.kr or 82-2-3010-5933 and refer to identifier – NCT01639092 (Study ID #AMC2012-1215)

Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in HBeAg+ CHB – Korea
Investigate whether telbivudine is more effective in inducing HBsAg decline compared with entecavir in HBeAg+ CHB patients who have achieved undetectable HBV DNA suppression with preceding entecavir tx. Contact: Dr. Young-Suk Lim limys@amc.seoul.kr or 82-2-3010-5933 and refer to identifier – NCT01595685 (Study ID #AMC2012-0201)

Switch from ADV to TDF in CHB for Suboptimal Resp. to ADV Combo Therapy – Korea Evaluate efficacy safety & tolerability of switching from adefovir to tenofovir in CHB patients who have suboptimal response to ADV-based combo rescue therapy due to resistance. Contact: Dr. BeomKyung Kim beomkkim@yuhs.ac or 82-2-2228-1930 or Dr. Jun Yong Park at 82-2-2228-1994 DRPJY@yuhs.ac and refer to identifier – NCT01595633 (Study ID #4-2011-0937)

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)

Efficacy of Telbivudine W/ or W/out Add-on Tenofovir Compared With Tenofovir – Korea
Compare antiviral effect and mutation rate between entecavir monotherapy group and telbivudine roadmap strategy in HBeAg+ CHB patients. Contact: Dr. Ki Tae Yoon at ktyoon@pusan.ac.kr or call 82-55-360-2362 or Surin Tak surintak@hanmail.net 82-55-360-1738 and refer to identifier – NCT01588912 (Study ID # CLDT600AKR07T)

Cohort Study in Korean Patients With CHB Receiving Pegylated Interferon – Korea
Evaluation of CHB patients with genotype C on Pegasys and the durability of HBeAg seroconversion/HBsAg loss and effect on long term disease progression. Contact: Dr. Young Eun Chon at NACHIVYS@yuhs.ac or call 02-2228-1936 and refer to identifier - NCT01531166 (Study ID # 4-2011-0461)

Study of Sequential Therapy of Pegasys following Entecavir in CHB – Korea
Evaluate safety and efficacy of PEG-IFN following Entecavir vs. PEG-IFN monotherapy in HBeAg (+) patients. Contact: Joo Hyun Sohn at +82-31-560-2225 sonjh@hanyang.ac.kr or Dae-Won Jun at +82-2-2290-8338 noshin@hanyang.ac.kr Refer to identifier – NCT01220596 (Study ID # ML25206)

Evaluate Efficacy and Safety of Clevudine and pegIFN in Sequence vs. Clevudine Alone or Clevudine and pegIFN Sequential in HBeAg (+) CHB Patients – Korea
Evaluate efficacy and safety of Clevudine + peg-IFN in sequence vs. Clevudine alone in CHB HBeAg(+) patients. Contact: Dr. Lee Chang Don at +82-31-820-3000 and refer identifier – NCT01264367 (Study ID # CMC-403)

Lamivudine plus Adefovir vs. Telbivudine plus Adefovir in Lamivudine Resistant CHB – Korea
Compare efficacy of continuing LAM + ADV vs. switching to Telbivudine + ADV in patients with poor response to LAM + ADV. Contact: Dr. Han Jak Ryu at +82-10-2329-2379 or hanjak@yuhs.ac or Dr. Jun Yong Park at +82-2-2228-1994 or DRPJY@yuhs.ac , and refer to identifier-NCT01270165 (Study ID # Sebivio-Ahn-01)

Development of Diagnostic Biomarker Panels for Hepatitis B and Liver Cancer – Malaysia
Develop biological markers that could be indicators for disease-inducing and carcinogenic potential of the virus. Contact: Clinical Research Centre at +603-404-39300 ext. 113 shanthini@crc.gov.my and refer to identifier - NCT01310062 (Study ID # 09-317-3991)

PEG-Interferon Alfa-2a Add-On Study in HBeAg Neg CHB (PADD) – 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. Harry LA Janssen at +31-10-7035942 h.janssen@erasmusmc.nl or Dr. Pauline Arends at +31-10-7031618 or p.arends@erasmusmc.nl and refer to identifier - NCT01373684 (Study ID # HBV 11-01)

Lowering Viral Load with Nucleos(T)ide Analogues Prior to PEG TX to Increase Sustained Response in HBeAg+ CHB (PEGON) – Netherlands, China
Investigate sustained off-treatment response to peginterferon alfa-2b in chronic hepatitis B HBeAg+ patients who are pre-treated with nucleos(t)ide analogues. Contact: Dr. Harry LA Janssen at +31-10-7035942 M.HOOGENDOORN@erasmusmc.nl or Dr. Pauline Arends at +31-10-7031618 or p.arends@erasmusmc.nl and refer to identifier - NCT01532843 (Study ID # HBV 11-02)

Genetic Study of Peginterferon Treatment in CHB Patients: (GIANT-B) – Netherlands
Collect clinical and virological data on CHB patients previously treated with Peg-IFN to see if IL28B gene polymorphisms are associated with response to PEG IFN therapy. Contact: Dr. Willem Pieter Brouwer w.p.brouwer@erasmusmc.nl, +31107033042 and refer to identifier - NCT01401400 (Study ID # HBV-10-03)

Cohort of Hepatitis B Research of Amsterdam – Netherlands
Observational cohort study to determine whether historic HBV viral load is associated with the risk of HBV related cirrhosis or mortality in a cohort of non-Asian individuals with CHB. Contact Dr. Soeradj Harkisoen at +31 88 7556228 or s.harkisoen@umcutrecht.nl and refer to identifier - NCT01462981 (Study ID # COBRA)

HBsAg Loss in CHB Patients with Low Viral Load – Netherlands
Investigate proportion of HBeAg negative, inactive carriers (DNA < 20K IU/ml) who will lose HBsAg when treated with PEG +Adefovir, or PEG + Tenofovir. Contact Dr. Henk Reesink at +31 20 5662787 or h.w.reesink@amc.nl, or Dr. Annikki de Niet at +31 20 5668278 a.deniet@amc.nl and refer to identifier - NCT00973219 (Study ID # TTM16002, ABR no.: 28338)

Observational Study of Pegasys in CHB Patients Who Failed Antiviral Treatment with Nucleos(t)ide Analogues – Poland
Determine if DV-601, a therapeutic vaccine, will be well tolerated and induce virological and immunological response in CHB patients. Contact: www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) genentechclinicaltrials@druginfo.com and reference Study ID Number ML28346. Identifier – NCT01794234 (Study ID # ML28346)

Study to Assess DV-601 in Subjects with CHB – Poland
Determine if DV-601, a therapeutic vaccine, will be well tolerated and induce virological and immunological response in CHB patients. Contact: Dr. K. Majorowski at +48 22 544 1756 or kmajorowski@grs-cro.com and refer to identifier – NCT01023230 (Study ID # DV4-HBT-02, 2009-010142-66)

Telbivudiune vs. Lamivudine for Maintenance Therapy of CHB and Neg HBV DNA Viral Load After 6 Months TX with Telbivudine – Switzerland
Show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine for patients showing no viral load after 24 week telbivudine treatment vs continuous treatment with telbivudine TX.. Contact: Markus Heim at +41 61 265 25 25 or markus.heim@unibas.ch or Michael Dill at +41 61 265 25 25 Michael.Dill@unibas.ch and refer to identifier - NCT01005238(Clinical Study # SASL28)

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)

HBV DNA Levels During Pregnancy in Chronic Hepatitis B –Taiwan
Elucidate the natural course of chronic HBV by serial HBV DNA and ALT levels during pregnancy. Contact: Mei-Hsia Ku +886-3-3281200 ext 8114, email kuvicky1029@gmail.com or Yi-Cheng Chen at 866-3-3281200 ext, 8107 yichengliver@gmail.com and refer to identifier - NCT01610115 (Study ID # HBV-P-01)

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)

Acoustic Radiation Force Impulse (ARFI) Technology in Prediction of Liver Fibrosis –Taiwan
Complete correlation and validity studies for liver fibrosis staging between ARFI elastosonography quantification and METAVIR by liver biopsy in CHB patients. Contact: Dr. Sheng-Hung Chen 886-4-22052121 ext 2264 shcvghtc@gmail.com and refer to identifier NCT01268865 (Study ID # DMR99-IRB-240)

Antiviral Therapy in Pregnant Women to Reduce Mother-to-Infant Transmission of HBV–Taiwan
Trial using tenofovir to reduce mother-to-infant transmission of HBV and to monitor status of mother and infant. Infants to receive vaccine and HBIG at birth. Contact: Dr. Mei-Hwei Chang 886-02-23123456 ext 71723 changmh@ntu.edu.tw or Dr. Huey-Ling Chen at 886-02-23123456 -ext. 71722 hueyling@ntu.edu.tw and refer to identifier - NCT01312012 (Study ID # 201010078M)

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: 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 of Telbivudine in CHB –Taiwan
Evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of HBV DNA (<=60 IU/ml) in HBeAg (+)/(-) patients at physician’s general practice. Contact: Hsiang-min Kung +886-3-3281200 ext 2224 or email hsiang0721@gmail.com and refer to identifier NCT00970216 (Study ID # PMST-Y-1)

Prednisolone Priming Study in Patients with CHB –Taiwan
Investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy. Contact: Mei-Hsia Ku +886-3-3281200 ext 8114 or email kuvicky1029@gmail.com and refer to identifier - NCT00778596 (Study ID # CST-L-1)

Pegasys Plus Entecavir vs. Entecavir only for HBeAg (+) CHB – Taiwan
Evaluate combo therapy of Pegasys plus Entecavir vs. Entecavir alone for HBeAg (+) CHB Patients. Contact: Dr. Pei-Jer Chen at 886-2-231-23456 ext 7072 or peijerchen@ntu.edu.tw, or Chun-Jen Liu 886-2-23-123456 ext 6644 cjliu@ntu.edu.tw , and refer to identifier – NCT00597259 (Study ID # 200710028M)

Entecavir with Pegasys Sequential Therapy vs. Pegasys for HBeAg (+) CHB –Taiwan
A placebo controlled randomized study to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response. National Taiwan University Hospital: Contact Dr. Chen-Hua Liu at 886-2-23123456 ext 63572 jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at 886-2-23123456 ext. 67307 kaojh@ntu.edu.tw and refer to identifier - NCT00921180 (Study ID # 950922)

Entecavir with Pegasys Sequential Therapy vs. Pegasys for HBeAg (-) CHB –Taiwan
A placebo controlled randomized study to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response for HBeAg (-) patients. Contact Dr. Chen-Hua Liu at 886-2-23123456 ext 63572 jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at 886-2-23123456 ext. 67307 kaojh@ntu.edu.tw and refer to identifier – NCT00917761 (Study ID # 950924)

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)

PEG-IFN Monotherapy vs. Combination with Entecavir in HBeAg (-) CHB –Thailand
Determine if combination of PEG-IFN and entecavir improves response and HBsAg clearance in HBeAg (-) patients vs. PEG-IFN alone. Contact Dr. Pisit Tangkijvanichan +662-256-4482 pisittkvn@yahoo.com and refer to identifier NCT01243281 (Study ID # Biochem2010/01)

ST-2 Non-Invasive Fibrosis Marker for CHB – Turkey
IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has recently been linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. Aim is to determine ability of ST2 to predict fibrosis in CHB. Contact Dr. Ismail H Kalkan +90 312 437 67 78 drismailster@gmail.com and refer to identifier NCT01633554 (Study ID # 24190708 Ikalkan24190708)

HBV CO-INFECTION TRIALS

*CHB=Chronic hepatitis B

TDF+3TC+EFV in Adults with HIV/HBV Coinfection –China only
Phase 4 single-arm trial evaluating the safety of tenofovir, lamivudine and efavirenz in adults with HIV-1 and HBV coinfection. Contact: Dr. Yasong Wu at 86-10-63132151 or yasongwu5@163.com and refer to identifier NCT01751555 (Study ID # co-us-104-0405)

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)

Lonafarnib for Chronic Hepatitis D –U.S. only
Study different doses of lonafarnib for those coinfected with HBV and HDV to see how it affects virus levels and other symptoms of HDV. Contact: Vanessa Haynes-Williams, RN at 301-402-0267 vhaynes@mail.nih.gov or Dr. Theo Heller at 301-402-7147 Theoh@mail.nih.gov Refer to identifier NCT01495585 (Study ID # 120046, 12-DK-0046)

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: Colleen Kotb, RN 202-857-7652, kotbch@mail.nih.gov or Dr. Shyamasundaran Kottilil at 301-435-0936 skottilil@niaid.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)

Surveillance Program for the Detection of HBV Resistance to Tenofovir in HIV-HBV Co-Infected Patients –Australia
Identify any changes in the HBV DNA that might be associated with resistance to tenofovir (TDF), to determine how long any changes take to occur and to determine the effect of these changes on the clinical response to TDF in HIV-HBV co-infected patients. Contact Jennifer Audsley, PhD at +61399030184 or jennifer.audsley@med.monash.edu.au (Refer to identifier - NCT00660361) (Study ID # ALF-55/08)

PEDIATRIC HBV CLINICAL TRIALS

*CHB=Chronic hepatitis B

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 and 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.

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: Sandy Lee at Sandy.Lee@gilead.com and refer to identifier – NCT01651403 (Study ID # GS-US-174-0144)

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) genentechclinicaltrials@druginfo.com and refer to Study ID # YV25718. Identifier – NCT01519960 (Study ID # YV25718, 2011-002732-70)

Entecavir/Pegylated Interferon in Immune Tolerant CHB Children – U.S. and Canada. Determine effectiveness of combination drug treatment with entecavir and pegylated interferon vs. no treatment in children ages 3-<18 who have immune tolerant CHB. Contact: Jennifer Dobberstein, MS at 412-624-5555 or jad183@pitt.edu and refer to identifier – NCT01368497 (Study ID # DK082864 HBRN IT Peds Trial.) Please click for trial details for parents and Health Care Provider details.

Phase III Study of Safety and Efficacy of Entecavir in Pediatric Patients with CHB –U.S. and International
Determine the safety and efficacy of entecavir in pediatric patients with CHB. Contact: In the U.S., refer to site specific phone number. For info outside the U.S., email - Clinical.Trials@bms.com with first line containing NCT# & Site#. Refer to identifier - NCT01079806 (Study ID # AI463-189)

HBV AND LIVER TRANSPLANTATION CLINICAL TRIALS

*CHB=Chronic hepatitis B

Registry Study for CHB Patients Receiving Nucleotide Therapy While on Orthotopic Liver Transplant List - U.S only
Approx. 5 year registry where patients are followed until orthotopic liver transplant, resolution of liver decompensation, death or registry conclusion. Contact: John Flaherty, PharmD at 650 522-5592 jflaherty@gilead.com Refer to identifier – NCT01590615 (Study ID # GX-US-174-0172)

Evaluation of HepaGam B in Combo with antivirals in HBV liver transplants - U.S. only
Assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of HBV reoccurrence following liver transplantation. Contact: Dr. Christine Hall at 204-275-4248 or chall@cangene.com, or Priya Uppin, MSc at 204-275-4531 puppin@cangene.com and refer to identifier – NCT00722332 (Study ID # HB-009)

Evaluating Blood Glucose during HBIG Infusion in Post Liver Transplant Patients -U.S only
Determine if use of HBIG post-transplant shows an increase in glucose using specific vs. non-specific glucose monitoring. Contact: Anna Argyris at 202 444-3700. Refer to identifier – NCT00998426 (Study ID # 2009-337)

Prophylaxis of HBV recurrence after Liver Transplantation -China
Evaluate Entecavir + HBIG vs. Lamivudine + HBIG vs. Adefovir + HBIG in HBV Transplant Patients. Contact: Dr. Zhi-Hai Peng at 0086-021-63240090 ext 3132 or pengpzh@hotmail.com or Dr. Tao Li 0086-021-63240090 ext. 3136 transplant@126.com and refer to identifier – NCT01139203 (Study ID # SH20100601)

Prevention of HBV Reinfection Post Liver Transplant via Entecavir -Germany
Determine if HBIG can be stopped early and replaced with Entecavir following HBV-induced liver transplantation to prevent reinfection. Contact: Dr. M. Manns at +495115320 ext 3305 or manns.michael@mh-hannover.de and refer to identifier – NCT01046799 (Study ID # 2008-005976-28)

Niuliva® for the Prevention of HBV Recurrence in Orthotopic Liver Transplant Recipients– Italy
Evaluate efficacy & safety of HBV immune globulin in the prophylaxis of HBV reinfection of HBV liver recipients, maintaining HBsAb levels for first six months post-transplant. Contact: Antonio Paez, MD at +34 935710700 or antonio.paez@grifols.com, or Michael Woodward at +34 935710700 mwoodward@grifols.com and refer to identifier - NCT01131065 (Study ID # IG 0907)

Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients -Korea
Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation. Contact: SKchemicals Clinical research team at +82-2-2008-2008 and refer to identifier – NCT01513850 (Study ID # Hepabulin IV_LTIII_2011)

HBV AND LIVER CANCER (or HEPATOCELLUAR CARCINOMA, HCC)

*CHB=Chronic hepatitis B

G-202 as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma – U.S. only
Evaluate activity and safety of G-202 in patients with HCC who have progressed after taking sorafenib and will be administered by IV infusion. Contact: Rachel Vasquez at 713-827-9525 or Research@oncologyconsultants.com and refer to identifier – NCT01777594 (Study ID # G-202-003)

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).

SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) – U.S. only
A Phase 2 Study of SGI-110 in the treatment of advanced hepatocellular carcinoma for patients who failed prior treatment with Sorafenib. Contact: Medplace Recruitment Center at 1-866-872-2349 and refer to identifier - NCT01752933 (Study ID#: SGI-110-03).

TRAVERSE: Pexa-Vec (JX-594) in patients with advanced hepatocellular carcinoma who have failed sorafenib treatment – International
Enrollment Completed. The TRAVERSE trial is a randomized, open-label Phase 2b trial to evaluate the efficacy and safety of Pexa-Vec (JX-594) plus best supportive care versus best supportive care in patients with advanced hepatocellular carcinoma who have failed sorafenib treatment. For additional information, please visit: www.traversetrial.com or contact patient_inquiry@jennerex.com and refer to identifier - NCT01387555 (Study ID#: JX594-HEP018).

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. Xin Wang at 301-496-2099 or xw3u@nih.gov and refer to identifier – NCT00913757 (Study ID # 999909149, 09-C-N149)

Viral & Host Factors Associated with HBV-related HCC – U.S. only
Sequence HBV genome in CHB patients and those with HCC due to CHB and identify mutations in HBV genome to determine risk factors. Contact: Mei-Sze Chua at 650-724-3525 or mchua@standford.edu and refer to identifier – NCT00767936 (Study ID # SU-05222008-1183, 98795, HEP0013)

Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients with Posthepatic Cirrhosis – China
Investigate impact of splenectomy coupled w/ portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatic cirrhosis after HBV or HCV infection. Contact: Prof. Chen Yong at 13891915509 or cheny@fmmuedu.cn and refer to identifier – NCT01201655 (Study ID # chenyong)

Risk of Exacerbation of CHB after Percutaneous Radiofrequency Ablation of HCC – China
Risk of exacerbation of CHB after RAF or hepatomy for HCC and effects on treatment outcome. Contact: Dr. Min-Shan Chen at 86-20-87343117 or Chminsh@mail.sysu.edu.cn and refer to identifier – NCT00720668 (Study ID # RFA006)

Efficacy of Antiviral Therapy After Radical Resection for HBV-related HCC – China
Antiviral treatment with Lamivudine or Entecavir following radical resection of HBV-related HCC. Contact: Dr. Xiang-Ming Lao at 86-20-87343115 or laoxming@mail.sysu.edu.cn and refer to identifier – NCT00768157) (Study ID # SYSUCC-HCC004)

HCC Treatment Using Transcatheter Arterial Chemoembolization (TACE) with Anti-HBV Therapy (TACEHBV) –China
Influence of anti-HBV therapy (Telbivudine) on safety and survival of HCC patients after TACE. Contact: Dr. Jinglin Xia at xia.jinglin@zs-hospital.sh.cn or Dr. Biwei Yang at yang.biwei@zs-hospital.sh.cn and refer to identifier – NCT01102335 (Study ID # LCI-001)

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)

Dose Escalation Study for Japanese Patients with HCC – Japan
Investigate the safety, tolerability, efficacy and PK for Japanese HCC patients who are not amenable to curative surgery or loco regional therapy. Contact: Boehringer Ingelheim Call Center at 1-800-243-0127 or clintriage.rdg@boehringer-ingelheim.com and refer to identifier – NCT01594125 (Study ID # 200906051R)

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)

HBV REACTIVATION AND LYMPHOMA

*CHB=Chronic hepatitis B

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. Contact: Jun Zhu at z@bjcancer.org or Yuquin Song at songyuquin622@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 z@bjcancer.org or Yuquin Song at songyuquin622@sina.com and refer to identifier – NCT01765231 (Study ID # PKU-2012111305)

Reactivation in HBsAg (-)/HBcAb(+) Lymphoma Patients Treated with RCHOP (IHBVRL) – China only
Identify incidence of HBV reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma with prior HBV undergoing RCHOP immuno-chemotherapy. Contact: Dr. Dongmei Ji at 86-21-64175590 ext. 8908, jidongmei2000@hotmail.com and refer to identifier – NCT01210287 (Study ID # 201010HBV)

Activation of HBV in HBsAg (-) But Anti-HBc Postive Patients – Japan only
Observational study to determine risk factors and strategies for individuals with resolved HBV (HBsAg (-) and Anti-HBc) and malignancy. Contact: Dr. Yoshihide Ueda at 81-75-751-3111 yueda@kuhp.kyoto-u.ac.jp and refer to identifier NCT00881036 (Study ID # HBV from anti-HBc positive)

Prophylactic Use of Entecavir for Non-Hodgkin’s Lymphoma Patients with Resolved HBV (HBVNHL) – Taiwan only
Prophylactic use of entecavir for patients with resolved HBV undergoing chemo for non-Hodgkin’s lymphoma. Contact: Dr. Yi-Hsiang Huang at 886-2-287-12121 ext 3352 yhhuang@vghtpe.gov.tw and refer to identifier – NCT00926757 (Study ID # VGHUST98-P1-07, VGHIRB98-01-08)

HBV REACTIVATION WITH OTHER AGENTS

*CHB=Chronic hepatitis B

Antiviral Prophylaxis for HBsAg(+),or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα – Korea
Analysis of effect of anti-TNF treatment on HBV reactivation among patients with systemic rheumatic disease, especially rheumatoid arthritis. Contact: Dr. Kichul Shin at 82-2-870-3198 kideb1@snu.ac.kr and refer to identifier – NCT01694264 (Study ID # H-1112-073-390)

Page last modified June 10, 2013