Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253
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This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection period for each patients will occur in the first 24 weeks.
Longitudinal Analysis of HBV-specific T Cell Responses in Patients With HBeAg-negative Chronic Hepatitis B (CHB) Treated With Pegylated Interferon Alfa-2a (40 KD) (Pegasys - RO258310). Immunology Sub-study of ML18253
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients 18-55 years of age
Chronic HBeAg negative hepatitis B
Liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment
Participation in study ML18253.
Interferon-based or any systemic anti-HBV therapy </= 12 months prior to first dose of study drug
Antiviral, anti-neoplastic, or immunomodulatory treatment </= 12 months prior to first dose of study drug
Nonresponders to previous interferon therapy and resistant to lamivudine
Co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV)
Compensated (Child A, score 6) or decompensated liver disease (Child B or C)
History or evidence of medical condition associated with chronic liver disease other than HBV