Continue Entecavir Rollover From China

Phase 3

Completed

• Conditions: Chronic Hepatitis B Virus
• Interventions: Drug: Entecavir

• Registration Number: NCT00975091
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Status Verified: 2009-11
• Disposition First Submitted: 2010-01-29
• Disposition First Submitted QC: 2010-01-29
• Last Update Submitted: 2010-01-29
• Disposition First Posted: 2010-02-02
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Exclusion Criteria

• Coinfection with HIV, HCV, or HDV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Entecavir 1.0	Entecavir	-
Entecavir 0.5	Entecavir	-

Primary Outcome Measures

Name	Time	Method
The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events	Through 3 years of dosing and up to 48 weeks of off treatment follow up

Secondary Outcome Measures

Name	Time	Method
The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort	Through 3 years of dosing