An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
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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.
Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) [ Time Frame: approximately 2.5 years ]
Secondary Outcome Measures
HBs levels in correlation with treatment outcome [ Time Frame: 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) [ Time Frame: approximately 2.5 years ]
For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization [ Time Frame: approximately 2.5 years ]
Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with chronic hepatitis B initiated on therapy with Pegasys
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
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