A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265
Completed
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT01645969
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, prospective, observational study will evaluate the one-year outcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from each patient for up to one year post-therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Inclusion Criteria
- Patients who were randomized to study Arm A of ML22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point
Exclusion Criteria
- Patients unwilling to provide informed consent or abide by the requirements of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment 1 year
- Secondary Outcome Measures
Name Time Method Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT) 1 year