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 and Co-Infection Clinical Trials

Updated: September 2009

U.S. CLINICAL TRIALS FOR CHRONIC HBV

NEW! - Tenofovir Alone vs. Tenofovir with Emtricitabine for CHB
Test whether the combination of two medications, tenofovir and emtricitabine, are safer and more effective for treating CHB than tenofovir alone. Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 or prpl@mail.cc.nih.gov (Study ID# 07-DK-0207 / Identifier - NCT00524173).

NEW! - Entecavir in Patients Receiving Liver Transplant Due to CHB – U.S. and International
A study to evaluate if entecavir will prevent the recurrence of hepatitis B virus in subjects who receive a liver transplant. In U.S., contact Clinical Trials Sites directly (Study ID # AI463-109 / Identifier - NCT00395018).

NEW! - Entecavir in Pediatric Patients with CHB
To determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied. In U.S., contact Clinical Trials sites directly (Study ID # AI463-028 / Identifier - NCT00423891).

NEW! - Tenofovir in Adolescents with CHB
To evaluate the effectiveness, safety, and tolerability of tenofovir in adolescents (aged 12-17 years) with CHB. Contact: Jane Anderson jane.anderson@gilead.com (Study ID # GS-US-174-0115 / Identifier - NCT00734162).

DEFINE STUDY: Entecavir + Adefovir Combination vs. Entecavir Monotherapy vs. Adefovir + Lamivudine Combination in Lamivudine-resistant CHB
To evaluate the effectiveness of entecavir plus adefovir combination therapy vs. entecavir monotherapy or adefovir plus lamivudine. In U.S., contact Clinical Trials Sites (Study ID #AI463-111 / Identifier - NCT00410202).

Telbivudine in Blacks/African Americans and Hispanics/Latinos with Compensated CHB
Investigate the efficacy of telbivudine during 52 weeks of treatment. Contact: Novartis (862) 778-8300 (Study ID # CLDT600AUS06 / Identifier - NCT00862706).

Tenofovir vs. Emtricitabine/Tenofovir Fixed-Dose in Subjects Resistant to Lamivudine
This study will compare the efficacy and safety of tenofovir to emtricitabine plus tenofovir in CHB subjects currently receiving lamivudine monotherapy with lamivudine associated resistance mutations. Contact: Jane Anderson jane.anderson@gilead.com (Study ID# GS-US-174-0121 / Identifier - NCT00737568).

Effect of Entecavir in Blacks/African Americans and Hispanics with CHB
A study to develop observational clinical experience with the use of entecavir in patients who are either of Black/African-American race or of Hispanic ethnicity. Contact: Clinical.Trials@bms.com (Study ID # AI463-085 / Identifier - NCT00371150).

HBV CO-INFECTION TRIALS

Innate Immunity in HIV Positive Patients co-Infected with HCV or HBV - AUSTRALIA
Data from this study will provide the first information 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) jennifer.audsley@med.monash.edu.au (Refer to # NCT00662194).

Hepatitis B Vaccine Genetics
This laboratory-based substudy of an effectiveness trial of two Hepatitis B vaccines in HIV-negative youths is being done to evaluate the genetic contribution to the individualized immune response. Contact Jenese Tucker, MPH at the National Institute of Child Health and Human Development (NICHD): jenesetucker@westat.com or 1-301- 517-4198 (Please refer to this study by its ClinicalTrials.gov identifier: NCT00142740).

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 Bayside Health/Gilead Sciences (Jennifer Audsley, PhD): jennifer.audsley@med.monash.edu.au (Refer to #NCT00660361).

INTERNATIONAL CLINICAL TRIALS FOR CHRONIC HBV

NEW! - Single-Dose Telbivudine in Children and Adolescents with CHB - BELGIUM, GERMANY
Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with CHB. Contact: Novartis +41 61 324 1111 (Study ID #CLDT600A2104 / Identifier- NCT00907894)

NEW! - Entecavir in Pediatric Patients with CHB - ARGENTINA, BELGIUM, BRAZIL, CANADA, S. KOREA, TAIWAN, UK
To determine the appropriate doses of entecavir to use in children and adolescents. Contact: Clinical.Trials@bms.com (Study ID # AI463-028 / Identifier - NCT00423891).

NEW! - Tenofovir in Adolescents with CHB - U.S., BULGARIA, FRANCE, POLAND, ROMANIA, SPAIN, TURKEY
To evaluate the effectiveness, safety, and tolerability of tenofovir in adolescents (aged 12-17 years) with CHB. Contact: Jane Anderson jane.anderson@gilead.com (Study ID # GS-US-174-0115 / Identifier - NCT00734162).

NEW! - Entecavir in Patients Receiving Liver Transplant Due to CHB - U.S., ARGENTINA, AUSTRALIA, BRAZIL, FRANCE, ITALY, S. KOREAN, SPAIN, TAIWAN
A study to evaluate if entecavir will prevent the recurrence of hepatitis B virus in subjects who receive a liver transplant. Contact: Clinical.Trials@bms.com (Study ID # AI463-109 / Identifier - NCT00395018).

NEW! - 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 Li at jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at kaojh@ntu.edu.tw (Study ID # 950924 / Identifier - NCT00917761).

NEW! - 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 Li at jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at kaojh@ntu.edu.tw (Study ID # 950922 / Identifier - NCT00921180).

NEW! - ADVANCE Study: PEGASYS + Adefovir in HBeAg (-) CHB - TURKEY
A 3 arm study to compare the efficacy and safety of combination therapy with PEGASYS + adefovir vs. PEGASYS monotherapy in HBeAg (-) CHB. Contact: Hoffmann-La Roche, +1 973 235 5000 (Study ID # ML20622 / Identifier - NCT00661076).

NEW! - PEGASYS + Entecavir in Treatment-Naive Patients with HBeAg (+) CHB - CHINA, HONG KONG
A 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg (+) CHB. Contact: Hoffmann-La Roche, +1 973 235 5000 (Study ID # ML20742 / Identifier - NCT00614471).

Effect of Entecavir in Blacks/African Americans and Hispanics CHB
A study to develop observational clinical experience with the use of entecavir in patients who are either of Black/African-American race or of Hispanic ethnicity. Contact: Clinical.Trials@bms.com (Study ID # AI463-085 / Identifier - NCT00371150).

Tenofovir vs. Emtricitabine/Tenofovir Fixed-Dose in Subjects Resistant to Lamivudine - U.S., AUSTRIA, CANADA, CZECH REPUBLIC, GERMANY, HUNGARY, NEW ZEALAND, POLAND, ROMANIA, SPAIN, TURKEY
This study will compare the efficacy and safety of tenofovir to emtricitabine plus tenofovir in CHB subjects currently receiving lamivudine monotherapy with lamivudine associated resistance mutations. Contact: Jane Anderson jane.anderson@gilead.com (Study ID# GS-US-174-0121 / Identifier - NCT00737568).

Efficacy Optimization Research of Telbivudine (EFFORT) - CHINA
To prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy. Contact: Dr. Jinlin Hou jlhou@fimmu.com (Study ID # MoH-01 / Identifier - NCT00962533).

Pegasys Monotherapy in Patients with CHB Who Have Participated in Previous Studies - New Zealand, Singapore, Taiwan
An open-label multicenter study with Pegasys monotherapy in eligible patients will have completed treatment on another donor protocol Contact: Hoffmann-La Roche, +1 973 235 5000 (Study ID # PP22612 / Identifier - NCT00962975)

Single-Arm Study of Telbivudine with or without add-on Tenofovir in HBeAg-Positive CHB - ARGENTINA, BRAZIL, GERMANY, THAILAND
Evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability. Novartis: +41 61 32 41111 (Study ID # CLDT600A2410 / Identifier - NCT00651209).

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), interferon 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 +86 013 58 05 84031 or email zhanlianh@21cn.com (Study ID # interferonshorttermnucleoside / Identifier - NCT00860626).

PEGASYS in Combination with Adefovir or Entecavir in HBeAg(+) CHB - TAIWAN
A 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg (+) CHB. Contact: Hoffmann-La Roche, +1 973 235 5000 (Study ID #ML21827 / Identifier - NCT00922207).

Antiviral Therapy in HBV-Related Advanced Liver Disease Patients - KOREA
A randomized, open label, phase IV, multicenter study for efficacy and safety of lamivudine versus entecavir therapy in HBV-related advanced liver disease. Contact: Dr. Jun Yong Park drpjy@yuhs.ac (Study ID # 4-2008-0296 / Identifier - NCT00823550).

Early Immunologic Response in Asian Patients with CHB treated with PEGASYS - NEW ZEALAND, SINGAPORE, TAIWAN
An open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naive Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Contact: Hoffmann-La Roche, +1 973 235 5000 (Study ID #PP22512 / Identifier - NCT00962871).

DEFINE STUDY: Entecavir + Adefovir Combination vs. Entecavir Monotherapy vs. Adefovir + Lamivudine Combination for CHB in Subjects with Lamivudine-resistant virus - U.S., ARGENTINA, AUSTRALIA, BRAZIL, CANADA, GREECE, HONG KONG, INDIA, ITALY, S. KOREA, MALAYSIA, PHILIPPINES, POLAND, RUSSION FEDERATION, SINGAPORE, TAIWAN, THAILAND
To evaluate the effectiveness of entecavir plus adefovir combination therapy vs. entecavir monotherapy or adefovir plus lamivudine. outside the U.S., email Clinical.Trials@BMS.com (Study ID #AI463-111 / Identifier - NCT00410202).

Telbivudine 600 mg Tablets in Chinese Patients with CHB - CHINA
The "Chinese PAC" study will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated CHB adults. Contact: Contact: Novartis +41 61 324 1111 (Study ID # CLDT600ACN03 / Identifier - NCT00781105).

Prednisolone Priming Study in Patients with CHB - TAIWAN
To 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 (Study ID # CST-L-1CST-L-1 / Identifier - NCT00778596).

Prospective Study of Telbivudine in the 5th Year of Treatment in Chinese Patients with Compensated CHB - CHINA
Study to evaluate efficacy and safety of Telbivudine in the fifth year of treatment in Chinese patients with compensated chronic HBV. Contact Novartis: +41 61 32 41111 (Study ID #CLDT600ACN04 / Identifier - NCT00646503).

Telbivudine in HBeAg (+) Compensated CHB - INDIA
Evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Contact: Novartis +41 61 32 41111 (Study ID #CLDT600AIN01 / Identifier - NCT00537537).

An Extension to Viral Kinetics Study of Telbivudine and Entecavir with CHB – S. KOREA
Evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study. Contact Novartis: +41 61 32 41111 (Study ID # CLDT600AKR02 / Identifier - NCT00467545).

Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS in Patients With HBeAg (+) CHB -AUSTRALIA, BRAZIL, CHINA, HONG KONG, S. KOREA, NEW ZEALAND, RUSSIAN FEDERATION, TAIWAN, THAILAND
A long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg (+) CHB. Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. Contact: Hoffmann-La Roche, +1 973 235 5000 (Study ID # MV22430 / Identifier - NCT00927082).

Combination or Sequential Treatment with PEGASYS and Entecavir in HBeAg (+) CHB - CHINA
A 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 1 year. Contact: Hoffmann-La Roche, +1 973 235 5000 (Study ID #ML22265 / Identifier NCT00940485).

HBV Kinetics During Treatment with Telbivudine - SPAIN
Prospective study to explore HBV kinetics in CHB during the first 24 weeks of treatment with telbivudine. Contact: Novartis +41 61 32 41111 (Clinical Study # CLDT600AES01 / Identifier - NCT00640588).

Suboptimal Responders to Adefovir Switching to Entecavir - CHINA
This study evaluates whether switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir. Contact: Bristol-Myers Squibb, Clinical.Trials@bms.com (Study ID # AI463-171 / Identifier - NCT00718887).

Efficacy and Tolerance of Naked DNA Vaccine in Patients with CHB - FRANCE
To determine if DNA vaccination of CHB patients under treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after treatment discontinuation. Contact Sandrine KAHI, PhD (French National Agency for Research on AIDS and Viral Hepatitis) s.kahi@vjf.inserm.fr (Study ID # 2007-001682-15 / Identification - NCT00536627).

Page last modified September 11, 2009