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.
Study Type
OBSERVATIONAL
Enrollment
50
Unnamed facility
Berlin, Germany
Unnamed facility
Leipzig, Germany
Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up
Time frame: from baseline to up to approximately 3 years
Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up
Time frame: from baseline to up to approximately 3 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)
Time frame: approximately 4 years
Percentage of patients with normalisation of serum alanine transaminase (ALT) levels
Time frame: approximately 4 years
Percentage of patients with HBsAg clearance/seroconversion
Time frame: approximately 4 years
Safety: Incidence of adverse events
Time frame: approximately 4 years
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