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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037062

AI463-060

Details and patient eligibility

About

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

Enrollment: 282 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

282 participants in 1 patient group

Entecavir

Experimental group

Treatment:

Drug: Entecavir