An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Entecavir

Criteria

Inclusion Criteria:

• Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);

• ALT ≤ 10 x upper limit of normal;

• Subjects must have well-compensated liver disease according to ALL of the following criteria;

1. Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5

2. Serum albumin ≥ 3 g/dL (≥ 30 g/L)

3. Serum bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)

Exclusion Criteria:

• Sex and Reproductive Status Exceptions

• Target Disease Exceptions

• Medical History and Concurrent Diseases