A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
Hepatitis B, Chronic
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- Adult participants between 18 to 65 years of age
- HBeAg-positive chronic HBV
- Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.
Exclusion Criteria:
- Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
- Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
- Evidence of decompensated liver disease
- Medical condition associated with chronic liver disease other than viral hepatitis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A (Naïve Participants)
Group B (Conventional Interferon Pretreated Participants)
Group C (Lamivudine Pretreated Participants)
Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms [mcg]) subcutaneously once weekly for 48 weeks.
Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.