Status:
COMPLETED
Continue Entecavir Rollover From China
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis B Virus
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief Summary
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 treat...
Eligibility Criteria
Inclusion
- 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
- Coinfection with HIV, HCV, or HDV
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00975091
Start Date
May 1 2004
End Date
August 1 2007
Last Update
February 2 2010
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