An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
Terminated
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT01794234
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
- Detectable HBV DNA (as measured by PCR)
- HBeAg positive and negative patients
- Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
- Elevated serum alanine aminotransferase (ALT)
- Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation
Exclusion Criteria
- Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
- Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
- Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
- Planned other than Pegasys antiviral treatment during Pegasys therapy
- Chronic liver disease other than chronic hepatitis B
- Pregnant or breast-feeding women
- Inadequate hematologic function
- Autoimmunology disorders
- Co-infection with chronic hepatitis C or HIV
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) approximately 2.5 years
- Secondary Outcome Measures
Name Time Method For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization approximately 2.5 years Safety: Incidence of adverse events approximately 2.5 years HBs levels in correlation with treatment outcome approximately 2.5 years For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) approximately 2.5 years