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

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis D, Chronic

Treatments: Drug: Peginterferon alfa-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02731131

ML18149

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group A: Monotherapy with Peginterferon alfa-2a

Experimental group

Description:

Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.

Treatment:

Drug: Peginterferon alfa-2a

Group B: Combination with Peginterferon alfa-2a + Ribavirin

Experimental group

Description:

Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa-2a