A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China

Bristol-Myers Squibb0 sites600 target enrollmentMay 2004

ConditionsChronic Hepatitis B Virus

InterventionsEntecavir

DrugsEntecavir

Overview

Phase: Phase 3
Intervention: Entecavir
Conditions: Chronic Hepatitis B Virus
Sponsor: Bristol-Myers Squibb
Enrollment: 600
Primary Endpoint: The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

August 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

•Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
•ALT ≤ 15 x upper limit of normal
•Compensated liver disease