A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.

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

Details

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

Criteria

Inclusion Criteria:

• Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening

• Positive anti-delta for at least 3 months prior to screening

• Positive hepatitis D virus (HDV) ribonucleic acid (RNA)

• A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)

• Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug

Exclusion Criteria:

• Antiviral therapy for CHD within the previous 6 months

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

• Evidence of decompensated liver disease

• Other medical condition associated with chronic liver disease

• Women with ongoing pregnancy or who are breast feeding