ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077636

Purpose

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: Copegus	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 and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

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

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

SVR [ Time Frame: 24 weeks post-treatment (ie week 40 or week 48) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Virological response [ Time Frame: End of treatment (ie week 16 or week 24) ] [ Designated as safety issue: No ]
Virological response [ Time Frame: 12 weeks post-treatment (ie week 28 or week 36) ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	1469
Study Completion Date:	March 2006

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 16 weeks Drug: Copegus 400mg po bid for 16 weeks
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 24 weeks Drug: Copegus 400mg po bid for 24 weeks

Eligibility

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

Criteria

Inclusion Criteria:

patients >=18 years of age;
CHC infection (genotype 2 or 3);
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.

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;
previous treatment with an IFN, pegylated IFN, ribavirin, viramidine, levovirin, or amantadine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077636

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Locations

United States, Alabama

BIRMINGHAM, Alabama, United States, 35294

MOBILE, Alabama, United States, 36693
United States, Alaska

ANCHORAGE, Alaska, United States, 99508
United States, Arizona

SCOTTSDALE, Arizona, United States, 85259

PHOENIX, Arizona, United States, 85006
United States, Arkansas

LITTLE ROCK, Arkansas, United States, 72205
United States, California

LONG BEACH, California, United States, 90822

LA JOLLA, California, United States, 92037-1030

PALO ALTO, California, United States, 94304-1509

SAN DIEGO, California, United States, 92154

SAN FRANCISCO, California, United States, 94121

SAN FRANCISCO, California, United States, 94115

LOS ANGELES, California, United States, 90048

SACRAMENTO, California, United States, 95825-2115

SAN DIEGO, California, United States, 92105

SAN DIEGO, California, United States, 92123

SAN LUIS OBISPO, California, United States, 93401
United States, Colorado

LITTLETON, Colorado, United States, 80120
United States, Connecticut

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

SARASOTA, Florida, United States, 34243

MIAMI, Florida, United States, 33136

WELLINGTON, Florida, United States, 33414

GAINESVILLE, Florida, United States, 32610-0214

JACKSONVILLE, Florida, United States, 32209

JACKSONVILLE, Florida, United States, 32207

ORLANDO, Florida, United States, 32803

TAMPA, Florida, United States, 33612

PENSACOLA, Florida, United States, 32514
United States, Georgia

AUSTELL, Georgia, United States, 30106

ATLANTA, Georgia, United States, 30309
United States, Hawaii

HONOLULU, Hawaii, United States, 96817
United States, Idaho

BOISE, Idaho, United States, 83702
United States, Illinois

MOLINE, Illinois, United States, 61265
United States, Indiana

INDIANAPOLIS, Indiana, United States, 46202
United States, Iowa

IOWA CITY, Iowa, United States, 52242

IOWA CITY, Iowa, United States, 52246
United States, Louisiana

NEW ORLEANS, Louisiana, United States, 70112

BATON ROUGE, Louisiana, United States, 70805
United States, Maryland

BALTIMORE, Maryland, United States, 21205

BALTIMORE, Maryland, United States, 21201
United States, Massachusetts

BOSTON, Massachusetts, United States, 02118

BURLINGTON, Massachusetts, United States, 01805

BOSTON, Massachusetts, United States, 02720

WORCESTER, Massachusetts, United States, 01655
United States, Michigan

DETROIT, Michigan, United States, 48202-2689

ANN ARBOR, Michigan, United States, 48109-0362
United States, Minnesota

PLYMOUTH, Minnesota, United States, 55446

MINNEAPOLIS, Minnesota, United States, 55417
United States, Missouri

ST LOUIS, Missouri, United States, 63104
United States, New Mexico

ALBUQUERQUE, New Mexico, United States, 87108
United States, New York

BRONX, New York, United States, 10468

MANHASSET, New York, United States, 11030

WILLIAMSVILLE, New York, United States, 14221

NEW YORK, New York, United States, 10003

NEW YORK, New York, United States, 10021

BINGHAMTON, New York, United States, 13903

BAYSIDE, New York, United States, 11358
United States, North Carolina

CHAPEL HILL, North Carolina, United States, 27599-7080

CHARLOTTE, North Carolina, United States, 28203

DURHAM, North Carolina, United States, 27710

FAYETTEVILLE, North Carolina, United States, 28304
United States, Ohio

CINCINNATI, Ohio, United States, 45267-0595

CLEVELAND, Ohio, United States, 44106
United States, Oregon

PORTLAND, Oregon, United States, 97220
United States, Pennsylvania

PITTSBURGH, Pennsylvania, United States, 15213

LANCASTER, Pennsylvania, United States, 17604-3200

HERSHEY, Pennsylvania, United States, 17033
United States, Rhode Island

PROVIDENCE, Rhode Island, United States, 02905

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

GERMANTOWN, Tennessee, United States, 38138
United States, Texas

DALLAS, Texas, United States, 75235-9151

FORT SAM HOUSTON, Texas, United States, 78234-3879

HOUSTON, Texas, United States, 77030

Dallas, Texas, United States, 75203
United States, Utah

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

WHITE RIVER JUNCTION, Vermont, United States, 05009-0001
United States, Virginia

RICHMOND, Virginia, United States, 23249

CHESAPEAKE, Virginia, United States, 23320-1706

CHARLOTTESVILLE, Virginia, United States, 22902

FALLS CHURCH, Virginia, United States, 22042
United States, Washington

SEATTLE, Washington, United States, 98195

KIRKLAND, Washington, United States, 98034

SEATTLE, Washington, United States, 98133

BELLEVUE, Washington, United States, 98004

SPOKANE, Washington, United States, 99220-3649

PUYALLUP, Washington, United States, 98372
United States, Wisconsin

MADISON, Wisconsin, United States, 53792
United States, Wyoming

CHEYENNE, Wyoming, United States, 82001
Australia

WOOLLOONGABBA, Australia, 4102

BRISBANE, Australia, 4029

MELBOURNE, Australia, 3181

ADELAIDE, Australia, 5000

KINGSWOOD, Australia
Canada, Alberta

EDMONTON, Alberta, Canada, T6G 2B7
Canada, Ontario

DOWNSVIEW, Ontario, Canada, M3N 2V7

MISSISSAUGA, Ontario, Canada, L5M 2V8
France

VANDOEUVRE-LES-NANCY, France, 54511

TOULOUSE, France, 31059

CRETEIL, France, 94010

NICE, France, 06202

GRENOBLE, France, 38043

RENNES, France, 35033

CLICHY, France, 92118

STRASBOURG, France, 67091

MARSEILLE, France, 13001
Germany

HOMBURG, Germany, 66424

KIEL, Germany, 24105

BERLIN, Germany, 13353

FREIBURG, Germany, 79106

DÜSSELDORF, Germany, 40225

HANNOVER, Germany, 30623
Italy

PISA, Italy, 56124

MILANO, Italy, 20121

BOLOGNA, Italy, 40138

BERGAMO, Italy, 24128

NAPOLI, Italy, 80131

PAVIA, Italy, 27100
New Zealand

OTAHUHU, New Zealand
Puerto Rico

SANTURCE, Puerto Rico, 00909

PONCE, Puerto Rico, 00716

SAN JUAN, Puerto Rico, 00936-5067

SAN JUAN, Puerto Rico, 00921-3200
Spain

VALENCIA, Spain, 46014

SEVILLA, Spain, 41013

MADRID, Spain, 28006

BARCELONA, Spain, 08803

MADRID, Spain, 28007

BARAKALDO, Spain, 48903

MADRID, Spain, 28034

BARCELONA, Spain, 08025

MADRID, Spain, 08029

BADALONA, Spain, 08915

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV17317
Study First Received:	February 10, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077636 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-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 27, 2009