Continue Entecavir Rollover From China

Bristol-Myers Squibb600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Chronic Hepatitis B Virus

Interventions

EntecavirDRUG

Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started

EntecavirDRUG

Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events

Time frame: Through 3 years of dosing and up to 48 weeks of off treatment follow up

Secondary Outcomes

The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort

Time frame: Through 3 years of dosing

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.