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

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00087646

Run by

Hoffmann-La Roche

People needed

948

Starts

2003-09-01

Expected to finish

2008-05-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — San Diego, California, United States
• Study site — Ukiah, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Des Moines, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Florham Park, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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