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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