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

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug); Ribavirin (Drug); Ribavirin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

Official 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Sustained virological response rate

Secondary outcome:

Percentage of patients with >=2log drop in HCV-RNA

Percentage of patients with undetectable HCV-RNA

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

BRUXELLES 1200, Belgium

GENT 9000, Belgium

LEUVEN 3000, Belgium

RIO DE JANEIRO 20270, Brazil

CLICHY 92118, France

LYON 69288, France

MONTPELLIER 34295, France

TOULOUSE 31059, France

CRETEIL 94010, France

MARSEILLE 13385, France

PARIS 75651, France

LILLE 59037, France

PESSAC 33600, France

BOCHUM 44791, Germany

HEIDELBERG 69120, Germany

KIEL 24105, Germany

KÖLN 50937, Germany

HOMBURG 66424, Germany

FREIBURG 79106, Germany

BERLIN 13353, Germany

HAMBURG 20251, Germany

MÜNSTER 48149, Germany

MAINZ 55101, Germany

WÜRZBURG 97080, Germany

DÜSSELDORF 40225, Germany

KASSEL 34125, Germany

MÜNCHEN 81377, Germany

HANNOVER 30625, Germany

OBERHAUSEN 46145, Germany

BONN 531105, Germany

DÜSSELDORF 40237, Germany

FRANKFURT AM MAIN 60590, Germany

ERLANGEN 91054, Germany

KÖLN 50924, Germany

HEIDELBERG 69115, Germany

MÜNCHEN 80337, Germany

FRANKFURT AM MAIN 60590, Germany

OBERHAUSEN 46045, Germany

HANNOVER 30623, Germany

HAMBURG 20246, Germany

HOMBURG 66424, Germany

THESSALONIKI 54642, Greece

THESSALONIKI 54638, Greece

ALEXANDROUPOLIS 68100, Greece

ATHENS 10552, Greece

ATHENS 15127, Greece

ATHENS 11527, Greece

HERAKLION 71100, Greece

MILANO 20122, Italy

PALERMO 90127, Italy

TORINO 10126, Italy

BOLOGNA 40138, Italy

ROMA 00133, Italy

BARI 70100, Italy

PADOVA 35128, Italy

LISBOA 1600, Portugal

PORTO 4050, Portugal

LISBOA 1150-314, Portugal

COIMBRA 3000-075, Portugal

GRANADA 18003, Spain

VALENCIA 46014, Spain

MALAGA 29010, Spain

ALICANTE 03010, Spain

SEVILLA 41014, Spain

MADRID 28035, Spain

BARCELONA 08036, Spain

MADRID 28046, Spain

MADRID 28007, Spain

SANTANDER 39008, Spain

HUDDINGE 14186, Sweden

GOETEBORG 41685, Sweden

LUND 22185, Sweden

ZÜRICH 8091, Switzerland

ANKARA 06100, Turkey

ISTANBUL 34390, Turkey

ISTANBUL 81190, Turkey

IZMIR 35100, Turkey

BIRMINGHAM B15 2TH, United Kingdom

MOBILE, Alabama 36693, United States

SCOTTSDALE, Arizona 85259, United States

VANCOUVER, British Columbia V5Z 1H2, Canada

SAN DIEGO, California 92123, United States

LOS ANGELES, California 90033, United States

UKIAH, California 95482, United States

PASADENA, California 91105, United States

FARMINGTON, Connecticut 06030, United States

SARASOTA, Florida 34243, United States

JACKSONVILLE, Florida 32256, United States

HOLLYWOOD, Florida 33021, United States

ATLANTA, Georgia 30309, United States

ATLANTA, Georgia 30308, United States

SAVANNAH, Georgia 31404, United States

CHICAGO, Illinois 60611, United States

CHICAGO, Illinois 60612, United States

DES MOINES, Iowa 50312, United States

BALTIMORE, Maryland 21224, United States

BOSTON, Massachusetts 02114, United States

BOSTON, Massachusetts 02215, United States

MINNEAPOLIS, Minnesota 55404-4565, United States

ROCHESTER, Minnesota 55905, United States

ST LOUIS, Missouri 63110, United States

KANSAS CITY, Missouri 64131, United States

FLORHAM PARK, New Jersey, United States

ALBUQUERQUE, New Mexico 87131, United States

WILLIAMSVILLE, New York 14221, United States

TORONTO, Ontario M5G 1X5, Canada

TORONTO, Ontario M6H 3M1, Canada

PHILADELPHIA, Pennsylvania 19104, United States

LANCASTER, Pennsylvania 17604-3200, United States

CRANSTON, Rhode Island 02920, United States

MEMPHIS, Tennessee 38120, United States

NASHVILLE, Tennessee 37211, United States

AUSTIN, Texas 78758, United States

HOUSTON, Texas 77054, United States

SALT LAKE CITY, Utah 84121, United States

BURLINGTON, Vermont 05401, United States

RICHMOND, Virginia 23249, United States

Ending date: May 2008
Last updated: June 17, 2008