A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression

Launched by HOFFMANN-LA ROCHE · Oct 12, 2012

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Eligibility criteria

• Inclusion Criteria:
• • Adult participants, 18 - 65 years of age
• • Chronic hepatitis B
• • Negative for HBeAg
• • On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months
• • HBsAg \>100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of Pegasys
• • Showing a steady HBsAg kinetic (HBsAg decrease \<0.5 log10 IU/ml from Week -12 to start of the Add-on phase)
• • Negative pregnancy test for women of childbearing potential
• • Women of childbearing potential and fertile males with female partners of childbearing potential must be using reliable contraception during and for 3 months after the Add-on phase
• Exclusion Criteria:
• • Coinfection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), Human Immunodeficiency virus (HIV)
• • Evidence of decompensated liver disease (Child-Pugh \>/=6)
• • History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
• • Known hypersensitivity to peginterferon alfa-2a
• • Pregnant of breastfeeding women
• • Evidence of alcohol and/or drug abuse
• • History of severe psychiatric disease, especially depression
• • History of immunologically mediated disease
• • History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• • History or evidence of severe pulmonary disease associated with functional limitations
• • History of severe cardiac disease
• • History of severe seizure disorder or current anticonvulsant use
• • Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry
• • History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment \</= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study
• • History or other evidence of severe retinopathy