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: April 2008

U.S. CLINICAL TRIALS FOR CHRONIC HBV

NEW! Truvada Versus Truvada Plus HBIG in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this study is to evaluate the safety and antiviral efficacy of the combination therapy (emtricitabine/tenofovir disoproxil fumarate), plus or minus Hepatitis B Immunoglobulin (HBIG) in preventing the recurrence of chronic hepatitis B after a patient (who was chronically infected with hepatitis B pre-liver transplant) has undergone a liver transplant. Contact Jane Anderson, PhD at Gilead Sciences: jane.anderson@gilead.com (Please refer to this study by its ClinicalTrials.gov identifier: NCT00507689).

NEW! Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age. Contact Dina Monte, BSN, CCRC at National Institute of Child Health and Human Development (NICHD): dinamonte@westat.com or 1-914-591-6170 (Please refer to this study by its ClinicalTrials.gov identifier: NCT00106964).

NEW! Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone. Contact Novartis: 862-778-8600 (Please refer to this study by its ClinicalTrials.gov identifier: NCT00376259 ).

NEW! Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks. Contact Pharmasset: clinical.trials@pharmasset.com (Please refer to this study by its ClinicalTrials.gov identifier: NCT00496002).

Tenofovir Alone vs. Combination with Emtricitabine
Assess the relative efficacy and safety of combination versus mono-therapy. A separate group of 40 previously treated patients will also be enrolled and randomized to mono- or combination-therapy to assess the safety profile of these agents. Contact Patient Recruitment and Public Liaison Office: (800) 411-1222 or prpl@mail.cc.nih.gov.

A Study of PEGASYS in HBeAg Positive Patients
Compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180µg weekly, in the treatment of HBeAg positive patients. Contact Hoffmann-La Roche: (800) 526-6367 (Please reference Study ID Number: PDO_WV19432).

Efficacy and Safety of Clevudine Compared with Adefovir
Compare in nucleoside treatment-naïve subjects the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks. Contact Pharmasset: clinical.trials@pharmasset.com (Please refer to this study by its ClinicalTrials.gov identifier: NCT00496158).

Entecavir plus Adefovir vs. Entecavir or Adefovir Monotherapy in Patients with Lamivudine-Resistant Virus
Evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir or adefovir monotherapy. Contact Bristol-Myers Squibb: Clinical.Trials@bms.com.

Lamivudine and Adefovir to Treat Chronic Hepatitis B
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. Contact Patient Recruitment and Public Liaison Office: (800) 411-1222 or prpl@mail.cc.nih.gov.

Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy
Evaluate the effectiveness of entecavir plus tenofovir combination therapy compared with entecavir monotherapy in patients with chronic hepatitis B who are treatment naïve. Contact Bristol-Myers Squibb: Clinical.Trials@bms.com (Please refer to this study by its ClinicalTrials.gov Identifer: NCT00410072).

Efficacy and Safety of Telbivudine in Treatment Naïve Patients with HBeAg-Positive HBV
Evaluate the combination of telbivudine and peginterferon for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy in patients with HBeAg + hepatitis B who are treatment naïve. Contact Novartis: 862-778-8300 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00412750).

Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
To learn if the study drug entecavir will prevent the recurrence of hepatitis B virus in subjects who receive an orthotopic liver transplant (OLT). Contact Bristol-Myers Squibb: Clinical.Trials@bms.com (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00395018).

Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
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 Bristol-Myers Squibb: Clinical.Trials@bms.com (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00371150).

Pegylated Interferon to Treat Chronic Hepatitis D
A study to evaluate the safety and effectiveness of pegylated interferon in treating hepatitis D virus (HDV) infection, which only infects those who already have chronic hepatitis B. Contact Patient Recruitment and Public Liaison Office at prpl@mail.cc.nih.gov or call (800) 411-1222 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00023322).

Study Comparing the Safety of Switching from Lamivudine to Adefovir Dipivoxil Versus Overlapping Lamivudine and Adefovir Before Adefovir Dipivoxil Monotherapy in Patients with Chronic Hepatitis B
Comparison of the safety of directly switching to Adefovir after a 12 week overlap period. Principal Investigator is Dr. Hie-Won Hann, Thomas Jefferson University Hospital, Philadelphia, PA. Contact Meejin Ahn at meejin.ahn@jefferson.edu or call 215-955-5806 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00307242).

FibroScan in Patients with Hepatitis B and C Presenting for Liver Biopsy
To examine the effectiveness of the FibroScan device in differentiating fibrosis in patients who are scheduled to have a liver biopsy. Sites in Boston, MA; Durham, NC; and St. Louis, MO. Contact Dr. Nezam H Afdhal at nafdhal@bidmc.harvard.edu or call 617-632-1118 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00125762).

Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program
To provide entecavir to HBV patients who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and have no other available treatment options. Contact: Bristol-Myers Squibb toll free at 1-866-892-1BMS, ext. 150 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00096811).

HBV CO-INFECTION TRIALS

NEW! 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 ).

Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C/Hepatitis B Co-Infection and Chronic Hepatitis C - Taiwan
A study comparing the efficacy of pegylated IFN plus ribavarin in hepatitis B and C co-infection vs. chronic hepatitis C to determine if different anti-viral regimens are needed. Contact Dr. Pei-Jer Chen, National Taiwan University Hospital, at peijer@ha.mc.ntu.edu.tw or call 886-2-23123456, Ext. 7072 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00154869).

Efficacy and Safety of PegIFN +/- FTC / TDF to Treat Chronic Hepatitis B in HIV-Coinfected Patients (the PEGPLUS Trial)- Germany
A study to evaluate the efficacy of pegylated interferon in the treatment of chronic hepatitis B in HIV-infected individuals, and to determine whether combination treatment of HBV-infection may be superior to pegylated interferon therapy alone. Contact Jürgen K Rockstroh, MD, PhD, University Hospital, Bonn, Germany at juergen.rockstroh@ukb.uni-bonn.de or call (49)-228-287, Ext. 6558 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00221286).

Pegylated Interferon Alfa-2b Plus Ribavirin in Chronic Hepatitis B and Delta- Taiwan
To study whether pegylated interferon alfa-2b in combination with ribavirin may be effective in the treatment of chronic hepatitis D patients who are also infected by hepatitis B virus. Study startedJuly 2005 at the National Taiwan University, Taipei, Taiwan. Contact: Pei-Jer Chen, MD, PhD, at peijer@ha.mc.ntu.edu.tw (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00117533).

INTERNATIONAL CLINICAL TRIALS FOR CHRONIC HBV

NEW! Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine - Australia
To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago. Contact GSK Clinical Trial Call Center: 1-877-379-3718 (Please refer to this study by its ClinicalTrials.gov identifier: NCT00524576).

NEW! Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth - Brazil, South Africa
In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age. Contact Dina Monte, BSN, CCRC at National Institute of Child Health and Human Development (NICHD): dinamonte@westat.com or 1-914-591-6170 (Please refer to this study by its ClinicalTrials.gov identifier: NCT00106964).

NEW! Hepatitis B Vaccine Booster Study - Spain
To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either HBvaxPRO® or Engerix-B®. The primary vaccination series (was given 4 to 6 years prior to study entry and consisted of a licensed hepatitis B vaccine product. The booster dose given in this study will be either an investigational Merck product (V232) or the licensed Engerix-B® vaccine. Contact Merck: 1-888-577-8839 (Please refer to this study by its ClinicalTrials.gov identifier: NCT00393523 ).

NEW! Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator - Canada
Evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Contact Carol LaJeunesse, CRC at University of British Columbia: 1-604-875-2757 or clajeunesse@cw.bc.ca (Please refer to this study by its ClinicalTrials.gov identifier: NCT00175435).

NEW! Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation - Taiwan
This study aims to investigate the necessity and efficacy of a hepatitis B virus (HBV) vaccine booster in children after liver transplantation. Contact Yen H Ni, MD, PhD at National Taiwan University Hospital: 1-886-2-23123456, ext 5451 or yhni@ha.mc.ntu.edu.tw (Please refer to this study by its ClinicalTrials.gov identifier: NCT00147459).

NEW! Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone - Hong Kong, Republic of Korea, Taiwan, Thailand
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil versus adefovir dipivoxil used alone. Contact Novartis: 862-778-8600 (Please refer to this study by its ClinicalTrials.gov identifier: NCT00376259 ).

Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive Compensated Chronic Hepatitis B - 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.

Adding Adefovir Dipivoxil vs. Switching to Entecavir in Patients with Lamivudine-Resistant Chronic Hepatitis B - Republic of Korea
Compare the efficacy of two strategies, combination of lamivudine and adefovir vs. entecavir monotherapy in patients with lamivudine resistance. Contact Hyung Joon Yim, M.D.: 82-31-412-6565 or gudwns21@medimail.co.kr.

A Study of PEGASYS in HBeAg Positive Patients - 12 Countries
Compare the efficacy and safety of PEGASYS® given for 24 or 48 weeks, and at doses of 90 or 180µg weekly. Contact Hoffmann-La Roche: 973-235 5000 (Please reference Study ID Number: PDO_WV19432).

A Study of PEGASYS in HBeAg Negative Patients with Lamivudine Resistant Virus - Turkey
Evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Contact Hoffmann-La Roche: 973-235-5000 (Please reference Study ID Number: RLI_ML20135).

Switching Study from Lamivudine to Clevudine vs. Continued Lamivudine - Republic of Korea
A multi-center, open, and randomized study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine against continued lamivudine treatment for 24 weeks. Contact: Heon Ju Lee, MD.PhD 82-2-828-8087 or winner0429@naver.com.

Entecavir plus Adefovir vs. Entecavir or Adefovir Monotherapy for Patients with Lamivudine-Resistant Virus - 19 Countries
To evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or adefovir monotherapy. Contact Bristol-Myers Squibb: Clinical.Trials@bms.com.

Long Term Treatment with Pegasys in HBeAg-negative Patients - Bulgaria
Evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients who have demonstrated response after treatment with interferon alfa. Contact Hoffmann-La Roche: 973-235-5000 (Please reference Study ID Number: RLI_ML20020).

To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-Positive) Compensated Chronic Hepatitis B (CHB) - India
This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy is assessed by hepatitis B virus (HBV) DNA non-detectability (PCR <300 copies/ml) by week 104 with CHB. Contact Novartis: +41 61 32 4111 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00537537).

A Study of PEGASYS® (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B (CHB) – United States, Australia, Brazil, China, France, Germany, Korea, New Zealand, Singapore, Taiwan, Thailand.
This study will compare the efficacy and safety of PEGASYS® given for 24 or 48 weeks, and at doses of 90 or 180µg weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Contact Hoffmann-La Roche: 973-235-5000 (Please reference Study ID Number: PDO_WV19432).

A Study of PEGASYS® (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B - Turkey
This study will evaluate the efficacy and safety of PEGASYS® in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Contact Hoffmann-La Roche: 973-235-5000 (Please reference Study ID Number: RLI_ML20135).

A Study of PEGASYS® (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B – Russia Federation
This study will assess the efficacy and safety of PEGASYS® in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. Contact Hoffmann-La Roche: 973-235-5000 (Please reference Study ID Number: RLI_ML20003).

SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS® (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB) - Bulgaria
This study will evaluate the efficacy and safety of intermittent treatment with PEGASYS® in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. Contact Hoffmann-La Roche: 973-235-5000 (Please reference Study ID Number: RLI_ML20020).

A Study of PEGASYS® (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B (CHB)- Estonia, Latvia, Lithuania
This study will evaluate the efficacy and safety of PEGASYS® in treatment-naive Baltic patients with HBeAg-positive chronic HBV. Contact Hoffmann-La Roche: 973-235-5000 (Please reference Study ID Number: RLI_ML20601).

Entecavir Plus Adefovir Versus Entecavir or Adefovir Monotherapy for Chronic Hepatitis B Infected Subjects With Lamivudine-Resistant Virus – Italy, Mexico
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or adefovir monotherapy. Contact Bristol-Myers Squibb: Clinical.Trials@bms.com (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00410202).

Study in Korea of Entecavir vs. Lamivudine in Adults with HBV
Compare the proportion of subjects who achieve a virologic response between the entecavir and lamivudine treatment groups. Contact Bristol-Myers Squibb: Clinical.Trials@bms.com (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00393484).

An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults with Chronic Hepatitis B - Republic of 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: 41613241111 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00467545).

Adefovir Dipivoxil for the Treatment of Chinese Compensated Chronic Hepatitis B (CHB) Patients
Open-label study of locally manufactured adefovir dipivoxil tablet to evaluate the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated chronic HBV. Contact GlaxoSmithKline Clinical Trials Call Center: 1-877-379-3718 or email XHSYLJD@eastday.com (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00441974).

Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection- Brazil, Mexico, South Africa
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. In the U.S., contact the BMS Call Center at 1-866-892-1BMS, Ext. 406. Outside the U.S. contact the BMS Call Center at 1-941-906-4711, Ext. 406 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00371150).

Peg-Intron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498) - Taiwan
An open label, randomized, comparative, multi-center study to investigate the efficacy profile of Peg-Intron. Secondary objectives are to compare the efficacy profile of Peg-Intron with that of adefovir, compare efficacy of Peg-Intron in lamivudine-naïve and lamivudine-experienced subjects, and to establish the safety profile of Peg-Intron in treating patients with HBeAg-positive chronic hepatitis B. Schering-Plough Clinical Trial Registry Call Center 1-888-772-8734 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00371761).

A 96 Week Study to Compare Tenofovir Versus Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B - Australia, Canada, France, Germany, Hong Kong, New Zealand, Singapore, Taiwan, United Kingdom
A study to evaluate and compare tenofovir disoproxil fumarate (DF), emtricitabine/tenofovir DF, and entecavir in the treatment of hepatitis B patients with decompensated liver disease. Contact Dr. Cary Moxham at cary.moxham@gilead.com or call 919-493-5980, ext. 7102 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00507507).

Safety Study of HBV DNA Vaccine to Treat Patients with Chronic HBV – Hong Kong, Singapore, Taiwan, Thailand
The aim of a therapeutic vaccine would be to enhance natural responses by boosting the appropriate cellular immune response to HBV. The purpose of this Phase I study is to evaluate the safety and tolerability profile of the HBV DNA vaccine, and test the ability of vaccine to reduce hepatitis B disease. Study started January 2006. (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00277576).

Hong Kong
Prince of Wales Hospital
Henry LY Chan 852 2632 3307, hlychan@cuhk.edu.hk
Alice Ho Miu Ling Nethersole Hospital
Nancy Leung 852 2689 3623

Singapore
National University Hospital
Seng G Lim 65 6772 4369, mdclimsg@nus.edu.sg
Singapore General Hospital
Wan C Chow 65 6321 4684, gm2cwc@sgh.com.sg

Taiwan
Cathay General Hospital, Taipei
Sien-Sin Yang 886 2 2708 2121 Ext. 3123, yangss@seed.net.tw
Chang Gung Memorial Hospital
I-Shyan Sheen 886 3 328 1200 Ext. 8102,
issheen.jks@msa.hinet.net

Treatment With Peginterferon Alfa-2a (40 KD) of Chronic Hepatitis B Patients, Who Have Failed Anti-Viral Treatment- Hong Kong
To investigate the HBV DNA suppression (and HBeAg seroconversion among HBeAg positive patients) pegylated interferon treatment at 24 weeks after end of treatment among patients who have failed anti-viral treatment in the past. Study started January 2005. Contact: Dr. Henry Chan, Chinese University of Hong Kong, at hylchan@cuhk.edu.hk or call (852)2632-2211 (Please refer to this study by its ClinicalTrials.gov Identifier: NCT00226382).