An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B
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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.
A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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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 ]
Secondary Outcome Measures :
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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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with chronic hepatitis B receiving treatment with Pegasys
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
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)