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

A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D

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.

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