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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR HEPSERA

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Clinical Trials for Hepsera

Trial ID Title Status Sponsor Phase Summary
NCT00158704 Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection. Terminated Gilead Sciences N/A Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.
NCT00230477 Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT Completed Gilead Sciences Phase 4 This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B. The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.
NCT00230477 Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT Completed GlaxoSmithKline Phase 4 This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B. The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.
NCT00230477 Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT Completed University of Washington Phase 4 This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B. The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.
NCT00307489 Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil Completed Gilead Sciences Phase 2 This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus deoxyribonucleic acid [HBV DNA]). Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of open-label FTC/TDF which may be continued through the end of the 168-week treatment period if there is a virologic response (HBV DNA < 400 copies/mL). Alternatively, subjects with confirmed HBV DNA < 400 copies/mL at or any time after Week 24 of double-blind treatment may continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may discontinue the study and begin commercially available HBV therapy rather than initiate open-label FTC/TDF.
NCT00371761 PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278) Completed Merck Sharp & Dohme Corp. Phase 3 This is an open label, randomized, comparative, multi-center study. Subjects will be screened within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Pegylated interferon alfa-2b (PegIntron) (1.5 mcg/kg body weight) or (2) oral adefovir 10 mg daily. The treatment phase will be 24 weeks for PegIntron and 48 weeks for adefovir. All subjects completing the assigned treatment phase will be followed up for an additional 48 weeks for PegIntron and 24 weeks for adefovir as observation phase. The primary objective is to establish the efficacy profile of PegIntron. Secondary objectives are to compare the efficacy profile of PegIntron with that of adefovir, compare efficacy of PegIntron in lamivudine-naïve and lamivudine-experienced subjects, and to establish the safety profile of PegIntron in treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.
NCT00410202 Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus Completed Bristol-Myers Squibb Phase 3 The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Hepsera

Condition Name

Condition Name for Hepsera
Intervention Trials
Hepatitis B 6
Chronic Hepatitis B 5
Hepatitis B, Chronic 4
Liver Transplantation 1
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Condition MeSH

Condition MeSH for Hepsera
Intervention Trials
Hepatitis B 16
Hepatitis 13
Hepatitis B, Chronic 12
Hepatitis A 10
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Clinical Trial Locations for Hepsera

Trials by Country

Trials by Country for Hepsera
Location Trials
Korea, Republic of 9
United States 8
Hong Kong 3
Malaysia 2
Spain 2
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Trials by US State

Trials by US State for Hepsera
Location Trials
New York 2
California 2
Connecticut 1
Virginia 1
Pennsylvania 1
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Clinical Trial Progress for Hepsera

Clinical Trial Phase

Clinical Trial Phase for Hepsera
Clinical Trial Phase Trials
Phase 4 6
Phase 3 3
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Hepsera
Clinical Trial Phase Trials
Completed 9
Unknown status 3
Terminated 2
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Clinical Trial Sponsors for Hepsera

Sponsor Name

Sponsor Name for Hepsera
Sponsor Trials
GlaxoSmithKline 4
Gilead Sciences 4
Bristol-Myers Squibb 3
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Sponsor Type

Sponsor Type for Hepsera
Sponsor Trials
Other 23
Industry 15
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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Julphar
UBS
Baxter
Farmers Insurance
McKinsey
US Army
Mallinckrodt

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