Trials / Completed
CompletedNCT00975091
Continue Entecavir Rollover From China
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 16 Years – 75 Years
- Healthy volunteers
- Not accepted
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 treatment of their chronic hepatitis B virus infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entecavir | Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started |
| DRUG | Entecavir | Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2007-08-01
- Completion
- 2007-08-01
- First posted
- 2009-09-11
- Last updated
- 2010-02-02
Source: ClinicalTrials.gov record NCT00975091. Inclusion in this directory is not an endorsement.