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

Phase 2

Completed

• Conditions: Hepatitis D, Chronic
• Interventions: Drug: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT02731131
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-02
• Study First Posted: 2016-04-07
• Status Verified: 2016-06
• Results First Submitted: 2016-06-03
• Results First Submitted QC: 2016-06-03
• Last Update Submitted: 2016-06-03
• Results First Posted: 2016-07-15
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Monotherapy with Peginterferon alfa-2a	Peginterferon alfa-2a	Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.
Group B: Combination with Peginterferon alfa-2a + Ribavirin	Ribavirin	Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
Group B: Combination with Peginterferon alfa-2a + Ribavirin	Peginterferon alfa-2a	Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment	Week 96	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment	Week 96	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.
Number of Participants With Negative HDV RNA at End of Treatment	Week 48	Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.
Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment	Week 48	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.
Number of Participants With ALT Normalization at 48 Weeks After End of Treatment	Week 96	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.
Number of Participants With ALT Normalization at End of Treatment	Week 48	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.