A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Peginterferon alfa-2a

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.