A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)

Study Overview
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Brief Summary
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This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.

Official Title
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Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)

Conditions
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Hepatitis D, Chronic

Intervention / Treatment
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* Drug: Pegylated Interferon (PEG-IFN) alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening Positive anti-delta for at least 3 months prior to screening Positive hepatitis D virus (HDV) ribonucleic acid (RNA) A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD) Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug Exclusion Criteria: Antiviral therapy for CHD within the previous 6 months Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) Evidence of decompensated liver disease Other medical condition associated with chronic liver disease Women with ongoing pregnancy or who are breast feeding

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegylated Interferon (PEG-IFN) alfa-2a<br>Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up. | Drug: Pegylated Interferon (PEG-IFN) alfa-2a<br>* Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.<br>* Other names: PEGASYS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay. | At Week 72 | 
| Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay. | At Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Normal ALT at Week 48 | Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay. | At Week 48 | 
| Percentage of Participants With Negative HDV RNA at Week 48 | Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay. | At Week 48 | 
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL. | At Weeks 48 and 72 | 
| Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay. | At Screening and at Weeks 48 and 72 | 
| Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay. | At Weeks 48 and 72 | 
| Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg. | At Weeks 48 and 72 |