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

Phase 3

Completed

• Conditions: Hepatitis D, Chronic
• Interventions: Drug: Pegylated Interferon (PEG-IFN) alfa-2a

• Registration Number: NCT02732639
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-08
• Status Verified: 2016-07
• Results First Submitted: 2016-07-15
• Results First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Results First Posted: 2016-08-26
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pegylated Interferon (PEG-IFN) alfa-2a	Pegylated Interferon (PEG-IFN) alfa-2a	Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72	At Week 72	Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Normal ALT at Week 48	At Week 48	Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72	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.
Percentage of Participants With Negative HDV RNA at Week 48	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.
Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels	At Screening and at Weeks 48 and 72	Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.
Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72	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.
Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72	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.