Continue Entecavir Rollover From China

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B Virus

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975091

AI463-050

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Entecavir 0.5

Active Comparator group

Treatment:

Drug: Entecavir

Drug: Entecavir

Entecavir 1.0

Active Comparator group

Treatment:

Drug: Entecavir

Drug: Entecavir