Chronic Hepatitis B Virus
Conditions
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 treatment of their chronic hepatitis B virus infection.
Interventions
DRUGEntecavir
Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events | Through 3 years of dosing and up to 48 weeks of off treatment follow up |
Secondary
| Measure | Time frame |
|---|---|
| The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort | Through 3 years of dosing |
Outcome results
None listed