A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

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

Details

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

Criteria

Inclusion Criteria:

• Adult patients, 18-65 years of age

• HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve

• Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)

Exclusion Criteria:

• Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)

• Evidence of decompensated liver disease

• A medical condition associated with chronic liver disease other than viral hepatitis