Continue Entecavir Rollover From China

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.

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Key information

Conditions

Chronic Hepatitis B Virus Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entecavir

Drug

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

Other names: Baraclude, BMS-200475

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Sep 11, 2009
Registry last updated: Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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