A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

June 3, 2016 updated by: Hoffmann-La Roche

A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D

This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

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

  • Italy
      • Cagliari, Italy, 09042

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 the prior 6 months
  • Positive anti-delta for the prior 3 months
  • Positive HDV RNA at Screening
  • Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
  • Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
  • Negative pregnancy and adequate contraceptive use

Exclusion Criteria:

  • Antiviral therapy for CHD within previous 3 months
  • Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
  • Increased risk of metabolic liver disease
  • Decompensated liver disease
  • Elevated bilirubin
  • Poor hematologic or renal function
  • Drug/alcohol abuse within 1 year prior to study
  • History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease
  • Organ transplantation with existing functional graft
  • Retinopathy or other ophthalmologic complication of diabetes or hypertension
  • Inclusion in another investigational trial within previous 12 weeks

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Monotherapy with Peginterferon alfa-2a
Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
Other Names:
  • Pegasys
Experimental: Group B: Combination with Peginterferon alfa-2a + Ribavirin
Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
Other Names:
  • Pegasys
Drug: Ribavirin
Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
Time Frame: Week 96
Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.
Week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment
Time Frame: Week 48
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.
Week 48
Number of Participants With ALT Normalization at 48 Weeks After End of Treatment
Time Frame: Week 96
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.
Week 96
Number of Participants With ALT Normalization at End of Treatment
Time Frame: Week 48
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.
Week 48
Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment
Time Frame: Week 96
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.
Week 96
Number of Participants With Negative HDV RNA at End of Treatment
Time Frame: Week 48
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.
Week 48

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

September 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 2, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18149

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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