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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis D, Chronic

Intervention / Treatment
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* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Monotherapy with Peginterferon alfa-2a<br>Participants will receive peginterferon alfa-2a alone, administered over 48 weeks. | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.<br>* Other names: Pegasys;|
| Experimental: Group B: Combination with Peginterferon alfa-2a + Ribavirin<br>Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks. | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.<br>* Other names: Pegasys;Drug: Ribavirin<br>* Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.<br>* Other names: Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Week 96 | 
| Number of Participants With Negative HDV RNA at End of Treatment | 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. | Week 48 |