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

July 15, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 021105
      • Bucharest, Romania, 022328
      • Cluj-napoca, Romania, 400162
      • Constanta, Romania
      • Craiova, Romania
      • Iasi, Romania, 700111
      • Timisoara, Romania, 293406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Pegylated Interferon (PEG-IFN) alfa-2a
Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
Other Names:
  • PEGASYS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
At Screening and at Weeks 48 and 72
Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18788

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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