A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is <50.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• male adults of Southeast and/or East Asian origin, 18-55 years of age

• HBeAg-positive chronic hepatitis B

• detectable HBV DNA

Exclusion Criteria:

• prior antiviral therapy for chronic hepatitis B

• evidence of bridging fibrosis, cirrhosis or decompensated liver disease

• positive test at screening for HAV (IgM), HCV, HDV or HIV

• history or evidence of medical condition associated with chronic liver disease

• antineoplastic or immunomodulatory treatmentdrug