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

Bristol-Myers Squibb (BMS) logo

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;

  • Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5
  • Serum albumin ≥ 3 g/dL (≥ 30 g/L)
  • 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

Trial contacts and locations

48

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Data sourced from clinicaltrials.gov

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