A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
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
2 other identifiers
interventional
30
6 countries
23
Brief Summary
This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
September 13, 2013
CompletedOctober 30, 2013
September 1, 2013
2.9 years
October 23, 2008
July 5, 2013
September 30, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced at Least 1 Adverse Event.
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Baseline through 24 weeks after the end of treatment (up to 72 weeks)
Study Arms (1)
Pegylated-interferon alfa-2a plus ribavirin
EXPERIMENTALParticipants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Interventions
Pegylated-interferon alfa-2a was administered subcutaneously once weekly.
Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing \< 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.
Eligibility Criteria
You may qualify if:
- Adult patients, ≥ 18 years of age.
- Chronic hepatitis C (CHC) patients with compensated liver disease (Child-Pugh A) who have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol.
You may not qualify if:
- Evidence of decompensated liver disease (Child B or C cirrhosis).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Chapel Hill, North Carolina, 27599-7584, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Providence, Rhode Island, 02905, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Vancouver, British Columbia, V5Z 1H2, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Toronto, Ontario, M5G 1L7, Canada
Unknown Facility
Clichy, 92118, France
Unknown Facility
Berlin, 10969, Germany
Unknown Facility
Cologne, 50924, Germany
Unknown Facility
Frankfurt am Main, 60590, Germany
Unknown Facility
Badalona, 08915, Spain
Unknown Facility
Barcelona, 08003, Spain
Unknown Facility
Madrid, 28222, Spain
Unknown Facility
Valencia, 46014, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2008
First Posted
December 2, 2008
Study Start
April 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 30, 2013
Results First Posted
September 13, 2013
Record last verified: 2013-09