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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR BARACLUDE

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Clinical Trials for Baraclude

Trial ID Title Status Sponsor Phase Summary
NCT00065507 Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation Completed Bristol-Myers Squibb Phase 3 This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
NCT00298363 Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease. Completed Gilead Sciences Phase 2 This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus. A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.
NCT00410072 Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B Completed Bristol-Myers Squibb Phase 3 The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
NCT00605384 A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection Terminated Bristol-Myers Squibb Phase 3 The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment will also be studied.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Baraclude

Condition Name

Condition Name for Baraclude
Intervention Trials
Chronic Hepatitis B 8
Hepatitis B 5
Hepatitis B, Chronic 4
Hepatitis 1
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Condition MeSH

Condition MeSH for Baraclude
Intervention Trials
Hepatitis B 20
Hepatitis 19
Hepatitis A 15
Hepatitis B, Chronic 13
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Clinical Trial Locations for Baraclude

Trials by Country

Trials by Country for Baraclude
Location Trials
United States 31
China 12
Canada 9
Korea, Republic of 5
Brazil 5
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Trials by US State

Trials by US State for Baraclude
Location Trials
New York 4
California 4
Michigan 3
Florida 3
Illinois 2
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Clinical Trial Progress for Baraclude

Clinical Trial Phase

Clinical Trial Phase for Baraclude
Clinical Trial Phase Trials
Phase 4 12
Phase 3 3
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Baraclude
Clinical Trial Phase Trials
Completed 8
Unknown status 5
Recruiting 4
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Clinical Trial Sponsors for Baraclude

Sponsor Name

Sponsor Name for Baraclude
Sponsor Trials
Bristol-Myers Squibb 7
Seoul St. Mary's Hospital 2
Peking University 2
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Sponsor Type

Sponsor Type for Baraclude
Sponsor Trials
Other 20
Industry 13
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