A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

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

Details

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

Criteria

Inclusion Criteria:

• Adult patients, >=18 and
• HBeAg positive chronic hepatitis B

• Pre-treatment with entecavir for 9-36 months

Exclusion Criteria:

• Antiviral, antineoplastic or immunomodulatory treatment

• Co-infection with active hepatitis A, C or D, or HIV

• Evidence of decompensated liver disease

• History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis