A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 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 18-70 years of age

• Positive test result for HBsAg for >6 months

• Naive to treatment for HBV

• On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion Criteria:

• Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)

• Decompensated liver disease

• Hepatocellular cancer

• Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug

• Medical condition associated with chronic liver disease