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

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis D, Chronic

Treatments: Drug: Pegylated Interferon (PEG-IFN) alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02732639

ML18788

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Pegylated Interferon (PEG-IFN) alfa-2a

Experimental group

Description:

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

Treatment:

Drug: Pegylated Interferon (PEG-IFN) alfa-2a