REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy
1 other identifier
interventional
948
14 countries
104
Brief Summary
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2003
Longer than P75 for phase_4
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 12, 2004
CompletedFirst Posted
Study publicly available on registry
July 14, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
January 14, 2016
CompletedJanuary 14, 2016
December 1, 2015
4.7 years
July 12, 2004
December 10, 2015
December 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Sustained Virological Response Rate
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.
Up to 72 weeks (Group A) and 48 weeks (Group D)
Secondary Outcomes (7)
Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
At Week 48 and Week 72
Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
At Week 48 and Week 72
Percentage of Participants With Undetectable HCV-RNA
At Week 12, 24, 48 and EOT
Percentage of Participants With >=2log Drop in HCV-RNA
At Week 12 and 24
Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
At Week 12 and 24
- +2 more secondary outcomes
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
ACTIVE COMPARATORInterventions
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- CHC infection;
- liver biopsy (in \<24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women;
- Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for \>=12 weeks.
You may not qualify if:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Unknown Facility
Mobile, Alabama, 36693, United States
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Scottsdale, Arizona, 85259, United States
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Los Angeles, California, 90033, United States
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Pasadena, California, 91105, United States
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San Diego, California, 92123, United States
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Ukiah, California, 95482, United States
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Farmington, Connecticut, 06030, United States
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Bradenton, Florida, 34243, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32256, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30309, United States
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Savannah, Georgia, 31404, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Des Moines, Iowa, 50312, United States
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Baltimore, Maryland, 21224, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Minneapolis, Minnesota, 55404-4565, United States
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Rochester, Minnesota, 55905, United States
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Kansas City, Missouri, 64131, United States
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St Louis, Missouri, 63110, United States
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Florham Park, New Jersey, United States
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Albuquerque, New Mexico, 87131, United States
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Williamsville, New York, 14221, United States
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Lancaster, Pennsylvania, 17604-3200, United States
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Philadelphia, Pennsylvania, 19104, United States
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Cranston, Rhode Island, 02920, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37211, United States
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Austin, Texas, 78758, United States
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Houston, Texas, 77054, United States
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Salt Lake City, Utah, 84121, United States
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Burlington, Vermont, 05401, United States
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Richmond, Virginia, 23249, United States
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Rio de Janeiro, 20270-901, Brazil
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Vancouver, British Columbia, V5Z 1H2, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M6H 3M1, Canada
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Clichy, 92118, France
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Créteil, 94010, France
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Lille, 59037, France
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Lyon, 69288, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Paris, 75651, France
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Pessac, 33604, France
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Toulouse, 31059, France
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Berlin, 13353, Germany
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Bochum, 44791, Germany
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Bonn, 53127, Germany
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Cologne, 50937, Germany
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Düsseldorf, 40225, Germany
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Düsseldorf, 40237, Germany
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Erlangen, 91054, Germany
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Frankfurt am Main, 60596, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Homburg/saar, 66424, Germany
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Kassel, 34125, Germany
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Kiel, 24105, Germany
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Mainz, 55101, Germany
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München, 81377, Germany
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Oberhausen, 46145, Germany
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Würzburg, 97080, Germany
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Alexandroupoli, 68100, Greece
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Athens, 10552, Greece
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Athens, 11527, Greece
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Thessaloniki, 546 42, Greece
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Bari, 70100, Italy
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Bologna, 40138, Italy
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Milan, 20122, Italy
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Padua, 35128, Italy
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Palermo, 90127, Italy
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Roma, 00133, Italy
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Torino, 10126, Italy
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Coimbra, 3000-075, Portugal
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Lisbon, 1150-314, Portugal
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Lisbon, 1649-035, Portugal
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Alicante, 03010, Spain
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Barcelona, 08036, Spain
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Granada, 18003, Spain
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Madrid, 28007, Spain
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Madrid, 28035, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Santander, 39008, Spain
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Seville, 41014, Spain
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Valencia, 46014, Spain
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Gothenburg, 41685, Sweden
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Huddinge, 14186, Sweden
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Lund, 22185, Sweden
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Zurich, 8091, Switzerland
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Ankara, 06100, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Istanbul, 81190, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Birmingham, B15 2TH, United Kingdom
Related Publications (1)
Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martin A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.
PMID: 23442834DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
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 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2004
First Posted
July 14, 2004
Study Start
September 1, 2003
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
January 14, 2016
Results First Posted
January 14, 2016
Record last verified: 2015-12