A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Positive hepatitis B surface antigen (HBsAg) for the prior 6 months

• Positive anti-delta for the prior 3 months

• Positive HDV RNA at Screening

• Elevated ALT (1 to 10 times upper limit of normal) prior to first dose

• Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)

• Negative pregnancy and adequate contraceptive use

Exclusion Criteria:

• Antiviral therapy for CHD within previous 3 months

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

• Increased risk of metabolic liver disease

• Decompensated liver disease

• Elevated bilirubin

• Poor hematologic or renal function

• Drug/alcohol abuse within 1 year prior to study

• History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease

• Organ transplantation with existing functional graft

• Retinopathy or other ophthalmologic complication of diabetes or hypertension

• Inclusion in another investigational trial within previous 12 weeks