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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR BARACLUDE


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All Clinical Trials for BARACLUDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00065507 ↗ Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation Completed Bristol-Myers Squibb Phase 3 2003-08-01 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.
NCT00096785 ↗ Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection Completed Bristol-Myers Squibb Phase 3 2004-12-01 The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
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 2006-04-01 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.
NCT00371150 ↗ Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection Completed Bristol-Myers Squibb Phase 4 2006-11-01 The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.
NCT00388674 ↗ Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection Completed Bristol-Myers Squibb 2006-12-18 The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.
NCT00393484 ↗ A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Completed Bristol-Myers Squibb Phase 4 2007-02-01 Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BARACLUDE

Condition Name

Condition Name for BARACLUDE
Intervention Trials
Chronic Hepatitis B 24
Hepatitis B 17
Hepatitis B, Chronic 12
Hepatitis B Virus 4
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Condition MeSH

Condition MeSH for BARACLUDE
Intervention Trials
Hepatitis B 68
Hepatitis 64
Hepatitis A 56
Hepatitis B, Chronic 48
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Clinical Trial Locations for BARACLUDE

Trials by Country

Trials by Country for BARACLUDE
Location Trials
United States 129
China 60
Japan 35
Brazil 30
Korea, Republic of 26
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Trials by US State

Trials by US State for BARACLUDE
Location Trials
New York 14
California 13
Florida 10
Texas 10
Connecticut 7
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Clinical Trial Progress for BARACLUDE

Clinical Trial Phase

Clinical Trial Phase for BARACLUDE
Clinical Trial Phase Trials
Phase 4 25
Phase 3 11
Phase 2 15
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Clinical Trial Status

Clinical Trial Status for BARACLUDE
Clinical Trial Phase Trials
Completed 35
Unknown status 18
Terminated 7
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Clinical Trial Sponsors for BARACLUDE

Sponsor Name

Sponsor Name for BARACLUDE
Sponsor Trials
Bristol-Myers Squibb 24
Third Affiliated Hospital, Sun Yat-Sen University 5
Arrowhead Pharmaceuticals 3
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Sponsor Type

Sponsor Type for BARACLUDE
Sponsor Trials
Other 62
Industry 43
NIH 1
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