An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B
Completed
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT01734018
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Adult patients, >/= 18 years of age
- HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
- Elevated serum ALT > ULN (upper limit of normal) but </=10 x ULN according to local label
Exclusion Criteria
- Contra-indications to Pegasys as detailed in the label
- Co-infection with hepatitis A, hepatitis B or HIV
- Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
- Pregnant or breastfeeding women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up from baseline to up to approximately 3 years Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up from baseline to up to approximately 3 years
- Secondary Outcome Measures
Name Time Method Percentage of patients with HBsAg clearance/seroconversion approximately 4 years Safety: Incidence of adverse events approximately 4 years Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients) approximately 4 years Percentage of patients with normalisation of serum alanine transaminase (ALT) levels approximately 4 years