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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings