A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

June 25, 2013 updated by: Hoffmann-La Roche

An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

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

  • Australia
      • Adelaide, Australia, 5000
      • Herston, Australia, 4006
  • Brazil
      • Ribeirao Preto, Brazil, 14049-900
      • Salvador, Brazil, 40150-130
      • Sao Paulo, Brazil, 01246-000
      • Sao Paulo, Brazil, 1323020
  • France
      • Vandoeuvre-les-nancy, France, 54511
  • Greece
      • Thessaloniki, Greece, 56429
  • Italy
      • Bergamo, Italy, 24128
      • Napoli, Italy, 80131
  • Poland
      • Warszawa, Poland, 01-201
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
      • San Juan, Puerto Rico, 00936-5067
      • San Juan, Puerto Rico, 00921-3200
      • Santurce, Puerto Rico, 00909
  • Spain
      • Barcelona, Spain, 08803
  • Taiwan
      • Taoyuan, Taiwan, 333
  • United Kingdom
      • Plymouth, United Kingdom, PL6 8DH
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35295-0005
    • California
      • La Jolla, California, United States, 92037-1030
      • Long Beach, California, United States, 90822
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92154
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Gainesville, Florida, United States, 32610
      • Gainesville, Florida, United States, 32610-0214
      • Jacksonville, Florida, United States, 32209
      • Miami, Florida, United States, 33136-1051
      • Orlando, Florida, United States, 32803
      • Orlando, Florida, United States, 32809
      • Sarasota, Florida, United States, 34243
      • Wellington, Florida, United States, 33414
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30309
      • Marietta, Georgia, United States, 30060
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Idaho
      • Boise, Idaho, United States, 83702
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Maryland
      • Baltimore, Maryland, United States, 21205
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
      • Worcester, Massachusetts, United States, 01655
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
    • New Jersey
      • Newark, New Jersey, United States, 07102
      • Vineland, New Jersey, United States, 08360
    • New York
      • Binghamton, New York, United States, 13903
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10016
      • New York, New York, United States, 10021
      • Poughkeepsie, New York, United States, 12601
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Statesville, North Carolina, United States, 28677
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Oregon
      • Portland, Oregon, United States, 97201
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
      • Philadelphia, Pennsylvania, United States, 19104
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Germantown, Tennessee, United States, 38138
    • Texas
      • Dallas, Texas, United States, 75203
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78215
    • Virginia
      • Charlottesville, Virginia, United States, 22906-0013
    • Washington
      • Bellevue, Washington, United States, 98004
      • Seattle, Washington, United States, 98133
      • Tacoma, Washington, United States, 98403

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:

  • Adult patients, ≥ 18 years of age.
  • Chronic hepatitis C.
  • Compensated liver disease (Child-Pugh Class A).
  • Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
  • Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
  • Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
  • For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
  • Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Male partners of women who are pregnant.
  • Patients with hemoglobinopathies.
  • Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
  • Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
  • Liver disease other than chronic hepatitis C, including hepatic carcinoma.

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: Peginterferon alfa-2a monotherapy or combined with ribavirin
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
Drug: Peginterferon alfa-2a
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
Other Names:
  • Pegasys
Drug: Ribavirin
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With at Least 1 Adverse Event
Time Frame: From Baseline to the end of the study (up to 72 weeks)
From Baseline to the end of the study (up to 72 weeks)

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, 2003

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV17590

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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