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

Bristol-Myers Squibb282 enrolled

Overview

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

282

Conditions

Chronic Hepatitis B

Interventions

EntecavirDRUG

Tablet, P.O. 0.5, 1 mg, once daily

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (48)

Outcomes

Primary Outcomes

Time frame: 24 weeks

Secondary Outcomes

Incidence of clinical adverse events and discontinuations due to adverse events of entecavir for each cohort

Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing

Incidence of laboratory abnormalities of of entecavir for each cohort

Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing

Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum

Time frame: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing

Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb)

Time frame: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing

Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT at Week 48

Time frame: Day 1, Week 48

Proportion of subjects who achieve HBV DNA levels by PCR assay less than the limit of quantification (LOQ)

Time frame: Day 1, Week 12, 24, and subsequent 24 week during dosing

Proportion of subjects positive for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ, normal serum ALT, and seroconversion

Time frame: Week 8, 16, 24 post dosing

Data from ClinicalTrials.gov

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Local Institution

Aichi-Gun, Aichi-ken, Japan

Local Institution

Nagoya, Aichi-ken, Japan

Local Institution

Nagoya, Aichi-ken, Japan

Local Institution

Nagoya, Aichi-ken, Japan

Local Institution

Chiba, Chiba, Japan

Local Institution

Onsen-Gun, Ehime, Japan

Local Institution

Fukuoka, Fukuoka, Japan

Local Institution

Kurume, Fukuoka, Japan

Local Institution

Gifu, Gifu, Japan

Local Institution

Ogaki-Shi, Gifu, Japan

...and 38 more locations