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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.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Copegus (Drug); Copegus (Drug); peginterferon alfa-2a [Pegasys] (Drug); peginterferon alfa-2a [Pegasys] (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

Summary

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.

Clinical Details

Official title: A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-na´ve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: SVR

Secondary outcome:

Virological response

Virological response

AEs, laboratory parameters, vital signs.

Eligibility

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

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.

Locations and Contacts

Adelaide 5000, Australia

Brisbane 4029, Australia

Kingswood, Australia

Melbourne 3181, Australia

Woolloongabba 4102, Australia

Clichy 92118, France

Creteil 94010, France

La Tronche 38700, France

Marseille 13285, France

Nice 06202, France

Rennes 35033, France

Strasbourg 67091, France

Toulouse 31059, France

Vandoeuvre-les-nancy 54511, France

Berlin 13353, Germany

D├╝sseldorf 40225, Germany

Freiburg 79106, Germany

Hannover 30625, Germany

Homburg/saar 66424, Germany

Kiel 24105, Germany

Bergamo 24128, Italy

Bologna 40138, Italy

Milano 20121, Italy

Napoli 80131, Italy

Pavia 27100, Italy

Pisa 56124, Italy

Otahuhu, New Zealand

Ponce 00716, Puerto Rico

San Juan 00936-5067, Puerto Rico

San Juan 00921-3200, Puerto Rico

Santurce 00909, Puerto Rico

Badalona 08915, Spain

Barakaldo 48903, Spain

Barcelona 08003, Spain

Barcelona 08025, Spain

Madrid 08029, Spain

Madrid 28006, Spain

Madrid 28007, Spain

Madrid 28034, Spain

Sevilla 41013, Spain

Valencia 46014, Spain

Birmingham, Alabama 35294, United States

Mobile, Alabama 36693, United States

Anchorage, Alaska 99508, United States

Edmonton, Alberta T6G 2B7, Canada

Phoenix, Arizona 85006, United States

Scottsdale, Arizona 85259, United States

Little Rock, Arkansas 72205, United States

La Jolla, California 92037-1030, United States

Long Beach, California 90822, United States

Los Angeles, California 90048, United States

Palo Alto, California 94304-1509, United States

Sacramento, California 95825-2115, United States

San Diego, California 92105, United States

San Diego, California 92123, United States

San Diego, California 92154, United States

San Francisco, California 94115, United States

San Francisco, California 94121, United States

San Luis Obispo, California 93401, United States

Littleton, Colorado 80120, United States

Farmington, Connecticut 06030, United States

Bradenton, Florida 34209, United States

Gainesville, Florida 32610-0214, United States

Jacksonville, Florida 32207, United States

Jacksonville, Florida 32209, United States

Miami, Florida 33136, United States

Orlando, Florida 32803, United States

Pensacola, Florida 32514, United States

Tampa, Florida 33612, United States

Wellington, Florida 33414, United States

Atlanta, Georgia 30309, United States

Austell, Georgia 30106, United States

Honolulu, Hawaii 96817, United States

Boise, Idaho 83702, United States

Moline, Illinois 61265, United States

Indianapolis, Indiana 46202, United States

Iowa City, Iowa 52242, United States

Iowa City, Iowa 52246, United States

Baton Rouge, Louisiana 70805, United States

New Orleans, Louisiana 70112, United States

Baltimore, Maryland 21201, United States

Baltimore, Maryland 21205, United States

Boston, Massachusetts 02118, United States

Boston, Massachusetts 02720, United States

Burlington, Massachusetts 01805, United States

Worcester, Massachusetts 01655, United States

Ann Arbor, Michigan 48109-0362, United States

Detroit, Michigan 48202-2689, United States

Minneapolis, Minnesota 55417, United States

Plymouth, Minnesota 55446, United States

St Louis, Missouri 63104, United States

Albuquerque, New Mexico 87108, United States

Bayside, New York 11358, United States

Binghamton, New York 13903, United States

Bronx, New York 10468, United States

Manhasset, New York 11030, United States

New York, New York 10003, United States

New York, New York 10021, United States

Williamsville, New York 14221, United States

Chapel Hill, North Carolina 27599-7584, United States

Durham, North Carolina 27710, United States

Fayetteville, North Carolina 28304, United States

Statesville, North Carolina 28677, United States

Cincinnati, Ohio 45267-0595, United States

Cleveland, Ohio 44106, United States

Downsview, Ontario M3N 2V7, Canada

Mississauga, Ontario L5M 2V8, Canada

Portland, Oregon 97220, United States

Hershey, Pennsylvania 17033, United States

Lancaster, Pennsylvania 17604-3200, United States

Pittsburgh, Pennsylvania 15213, United States

Cranston, Rhode Island 02920, United States

Providence, Rhode Island 02905, United States

Germantown, Tennessee 38138, United States

Dallas, Texas 75203, United States

Dallas, Texas 75235-9151, United States

Fort Sam Houston, Texas 78234-3879, United States

Houston, Texas 77030, United States

Salt Lake City, Utah 84121, United States

White River Junction, Vermont 05009-0001, United States

Charlottesville, Virginia 22902, United States

Chesapeake, Virginia 23320-1706, United States

Falls Church, Virginia 22042, United States

Richmond, Virginia 23249, United States

Bellevue, Washington 98004, United States

Kirkland, Washington 98034, United States

Puyallup, Washington 98372, United States

Seattle, Washington 98195, United States

Seattle, Washington 98133, United States

Spokane, Washington 99220-3649, United States

Madison, Wisconsin 53792, United States

Cheyenne, Wyoming 82001, United States

Additional Information

Starting date: December 2003
Last updated: August 17, 2015

Page last updated: August 23, 2015

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