Continue Entecavir Rollover From China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Hepatitis B Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir 0.5

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

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

Entecavir 1.0

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

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

Interventions

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Entecavir

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

Intervention Type DRUG

Entecavir

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

Intervention Type DRUG

Other Intervention Names

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Baraclude BMS-200475 Baraclude BMS-200475

Eligibility Criteria

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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