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

Hoffmann-La Roche12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis D, Chronic

Interventions

Peginterferon alfa-2aDRUG

Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.

RibavirinDRUG

Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Cagliari, Italy

Outcomes

Primary Outcomes

Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment

Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.

Time frame: Week 96

Secondary Outcomes

Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.

Time frame: Week 48

Number of Participants With ALT Normalization at 48 Weeks After End of Treatment

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.

Time frame: Week 96

Number of Participants With ALT Normalization at End of Treatment

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.

Time frame: Week 48

Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment

Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.

Data from ClinicalTrials.gov

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