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 - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00087646

Purpose

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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: Ribavirin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Sustained virological response rate [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with >=2log drop in HCV-RNA [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Percentage of patients with undetectable HCV-RNA [ Time Frame: Weeks 12, 24 and end of treatment ] [ Designated as safety issue: No ]

Enrollment:	948
Study Completion Date:	May 2008

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks Drug: Ribavirin 1000/1200mg po daily for 72 weeks
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks. Drug: Ribavirin 1000/1200mg po daily for 48 weeks
3: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 72 weeks Drug: Ribavirin 1000/1200mg po daily for 72 weeks
4: Active Comparator	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 48 weeks Drug: Ribavirin 1000/1200mg po daily for 48 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087646

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Locations

United States, Alabama

MOBILE, Alabama, United States, 36693
United States, Arizona

SCOTTSDALE, Arizona, United States, 85259
United States, California

SAN DIEGO, California, United States, 92123

PASADENA, California, United States, 91105

UKIAH, California, United States, 95482

LOS ANGELES, California, United States, 90033
United States, Connecticut

FARMINGTON, Connecticut, United States, 06030
United States, Florida

SARASOTA, Florida, United States, 34243

JACKSONVILLE, Florida, United States, 32256

HOLLYWOOD, Florida, United States, 33021
United States, Georgia

SAVANNAH, Georgia, United States, 31404

ATLANTA, Georgia, United States, 30308

ATLANTA, Georgia, United States, 30309
United States, Illinois

CHICAGO, Illinois, United States, 60611

CHICAGO, Illinois, United States, 60612
United States, Iowa

DES MOINES, Iowa, United States, 50312
United States, Maryland

BALTIMORE, Maryland, United States, 21224
United States, Massachusetts

BOSTON, Massachusetts, United States, 02114

BOSTON, Massachusetts, United States, 02215
United States, Minnesota

MINNEAPOLIS, Minnesota, United States, 55404-4565

ROCHESTER, Minnesota, United States, 55905
United States, Missouri

ST LOUIS, Missouri, United States, 63110

KANSAS CITY, Missouri, United States, 64131
United States, New Jersey

FLORHAM PARK, New Jersey, United States
United States, New Mexico

ALBUQUERQUE, New Mexico, United States, 87131
United States, New York

WILLIAMSVILLE, New York, United States, 14221
United States, Pennsylvania

PHILADELPHIA, Pennsylvania, United States, 19104

LANCASTER, Pennsylvania, United States, 17604-3200
United States, Rhode Island

CRANSTON, Rhode Island, United States, 02920
United States, Tennessee

MEMPHIS, Tennessee, United States, 38120

NASHVILLE, Tennessee, United States, 37211
United States, Texas

AUSTIN, Texas, United States, 78758

HOUSTON, Texas, United States, 77054
United States, Utah

SALT LAKE CITY, Utah, United States, 84121
United States, Vermont

BURLINGTON, Vermont, United States, 05401
United States, Virginia

RICHMOND, Virginia, United States, 23249
Belgium

BRUXELLES, Belgium, 1200

GENT, Belgium, 9000

LEUVEN, Belgium, 3000
Brazil

RIO DE JANEIRO, Brazil, 20270
Canada, British Columbia

VANCOUVER, British Columbia, Canada, V5Z 1H2
Canada, Ontario

TORONTO, Ontario, Canada, M5G 1X5

TORONTO, Ontario, Canada, M6H 3M1
France

CLICHY, France, 92118

LYON, France, 69288

CRETEIL, France, 94010

TOULOUSE, France, 31059

MONTPELLIER, France, 34295

MARSEILLE, France, 13385

PARIS, France, 75651

LILLE, France, 59037

PESSAC, France, 33604
Germany

BOCHUM, Germany, 44791

HEIDELBERG, Germany, 69120

KIEL, Germany, 24105

KÖLN, Germany, 50937

HOMBURG, Germany, 66424

FREIBURG, Germany, 79106

BERLIN, Germany, 13353

HAMBURG, Germany, 20251

MÜNSTER, Germany, 48149

OBERHAUSEN, Germany, 46145

WÜRZBURG, Germany, 97080

DÜSSELDORF, Germany, 40225

KASSEL, Germany, 34125

MÜNCHEN, Germany, 81377

HANNOVER, Germany, 30625

MAINZ, Germany, 55101

BONN, Germany, 531105

DÜSSELDORF, Germany, 40237

FRANKFURT AM MAIN, Germany, 60590

ERLANGEN, Germany, 91054
Greece

ATHENS, Greece, 10552

ALEXANDROUPOLIS, Greece, 68100

THESSALONIKI, Greece, 54642

Athens, Greece, 11527

THESSALONIKI, Greece, 54642
Italy

MILANO, Italy, 20122

PALERMO, Italy, 90127

ROMA, Italy, 00133

BOLOGNA, Italy, 40138

TORINO, Italy, 10126

BARI, Italy, 70100

PADOVA, Italy, 35128
Portugal

LISBOA, Portugal, 1600

PORTO, Portugal, 4050

LISBOA, Portugal, 1150-314

COIMBRA, Portugal, 3000-075
Spain

GRANADA, Spain, 18003

MAJADAHONDA, Spain, 28222

SEVILLA, Spain, 41013

VALENCIA, Spain, 46014

MALAGA, Spain, 29010

ALICANTE, Spain, 03010

SEVILLA, Spain, 41014

LA CORUNA, Spain, 15006

BARCELONA, Spain, 08036

MADRID, Spain, 28046

MADRID, Spain, 28007

SANTANDER, Spain, 39008
Sweden

LUND, Sweden, 22185

GOETEBORG, Sweden, 41685

HUDDINGE, Sweden, 14186
Switzerland

ZÜRICH, Switzerland, 8091
Turkey

ANKARA, Turkey, 06100

ISTANBUL, Turkey, 34390

ISTANBUL, Turkey, 81190

IZMIR, Turkey, 35100
United Kingdom

BIRMINGHAM, United Kingdom, B15 2TH

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MV17150
Study First Received:	July 12, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00087646 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2b
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 27, 2009