A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adults 18-70 years of age;

• HBeAg-negative chronic hepatitis B for >/=6 months;

• liver disease consistent with chronic hepatitis B.

Exclusion Criteria:

• interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy
• non-responders to previous interferon therapy;

• co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);

• hepatocellular cancer;

• compensated (Child A, score 6) or decompensated liver disease (Child B or C).