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

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

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

NCT02732639•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (7)

Bucharest, Romania

Cluj-Napoca, Romania

Constanța, Romania

Craiova, Romania

Iași, Romania

Timișoara, Romania

Key Dates

Start Date

October 1, 2005

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

August 26, 2016

Enrollment

ACTUAL participants

Conditions

Hepatitis D, Chronic

Interventions

Pegylated Interferon (PEG-IFN) alfa-2a

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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ACTIVE_NOT_RECRUITINGNA

Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection

NCT06603311

Compensated Liver Disease (Disorder)Hepatitis D, Chronic

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection