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Trial information
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
Status: Completed
Protocol number: MV17150
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
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.
Target sample size is 888.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Sustained virological response rate Time frame: 24 weeks post-treatment
Key secondary outcomes: 1. Percentage of patients with >=2log drop in HCV-RNA Time frame: Weeks 12 and 24
2. Percentage of patients with undetectable HCV-RNA Time frame: Weeks 12, 24 and end of treatment
Inclusion criteria: - 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.
Exclusion criteria: - 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:Belgium Brazil Canada France - Clichy
- Creteil
- Lille
- Lyon
- Montpellier
- Paris
- Pessac
- Toulouse
Germany - Berlin
- Bochum
- Bonn
- Düsseldorf
- Erlangen
- Frankfurt Am Main
- Freiburg
- Hamburg
- Hannover
- Heidelberg
- Homburg
- Kiel
- Köln
- Mainz
- München
- Münster
- Oberhausen
- Würzburg
Greece - Alexandroupolis
- Athens
- Heraklion
- Thessaloniki
Italy - Bari
- Bologna
- Milano
- Padova
- Palermo
- Roma
- Torino
Portugal Spain - Alicante
- Barcelona
- Granada
- Madrid
- Malaga
- Santander
- Sevilla
- Valencia
Sweden Switzerland Turkey United Kingdom United States - Mobile, AL
- Scottsdale, AZ
- Los Angeles, CA
- Pasadena, CA
- Ukiah, CA
- Farmington, CT
- Hollywood, FL
- Jacksonville, FL
- Sarasota , FL
- Atlanta, GA
- Savannah, GA
- Chicago, IL
- Des Moines, IA
- Baltimore, MD
- Boston, MA
- Minneapolis, MN
- Rochester, MN
- Kansas City, MO
- St Louis, MO
- Florham Park, NJ
- Albuquerque, NM
- Williamsville, NY
- Lancaster, PA
- Philadelphia, PA
- Cranston, RI
- Memphis , TN
- Nashville, TN
- Austin, TX
- Houston, TX
- Salt Lake City, UT
- Burlington, VT
- Richmond, VA
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