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.

NCT00077636 | Completed Phase 4 Results

• 1 other identifier: NV17317
• Study Type: interventional
• Target: 1,469
• Locations: 9 countries
• Sites: 132

Brief 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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virological Response (SVR)

  SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.

  Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)

Secondary Outcomes (6)

• Percentage of Participants With Virological Response at The End of Study Treatment

  Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)

• Percentage of Participants Virological Response 12 Weeks Post-Treatment

  Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 40 and Week 48

• Percentage of Participants With Marked Laboratory Abnormalities

  Up to Week 40 and Week 48

• Participants With Marked Abnormal Vital Signs

  Up to Week 40 and Week 48

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

Copegus DRUG

400mg po bid for 16 weeks

1

peginterferon alfa-2a [Pegasys] DRUG

180 micrograms sc weekly for 16 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (132)

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Birmingham, Alabama, 35294, United States

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Mobile, Alabama, 36693, United States

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Anchorage, Alaska, 99508, United States

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Phoenix, Arizona, 85006, United States

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Scottsdale, Arizona, 85259, United States

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Little Rock, Arkansas, 72205, United States

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La Jolla, California, 92037-1030, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90048, United States

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Palo Alto, California, 94304-1509, United States

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Sacramento, California, 95825-2115, United States

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San Diego, California, 92105, United States

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San Diego, California, 92123, United States

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San Diego, California, 92154, United States

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San Francisco, California, 94115, United States

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San Francisco, California, 94121, United States

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San Luis Obispo, California, 93401, United States

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Littleton, Colorado, 80120, United States

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Farmington, Connecticut, 06030, United States

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Bradenton, Florida, 34209, United States

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Gainesville, Florida, 32610-0214, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32209, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32803, United States

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Pensacola, Florida, 32514, United States

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Tampa, Florida, 33612, United States

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Wellington, Florida, 33414, United States

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Atlanta, Georgia, 30309, United States

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Austell, Georgia, 30106, United States

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Honolulu, Hawaii, 96817, United States

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Boise, Idaho, 83702, United States

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Moline, Illinois, 61265, United States

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Indianapolis, Indiana, 46202, United States

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Iowa City, Iowa, 52242, United States

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Iowa City, Iowa, 52246, United States

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Baton Rouge, Louisiana, 70805, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21205, United States

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Boston, Massachusetts, 02118, United States

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Boston, Massachusetts, 02720, United States

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Burlington, Massachusetts, 01805, United States

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Worcester, Massachusetts, 01655, United States

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Ann Arbor, Michigan, 48109-0362, United States

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Detroit, Michigan, 48202-2689, United States

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Minneapolis, Minnesota, 55417, United States

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Plymouth, Minnesota, 55446, United States

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St Louis, Missouri, 63104, United States

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Albuquerque, New Mexico, 87108, United States

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Bayside, New York, 11358, United States

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Binghamton, New York, 13903, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10003, United States

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New York, New York, 10021, United States

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The Bronx, New York, 10468, United States

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Williamsville, New York, 14221, United States

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Chapel Hill, North Carolina, 27599-7584, United States

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Durham, North Carolina, 27710, United States

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Fayetteville, North Carolina, 28304, United States

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Statesville, North Carolina, 28677, United States

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Cincinnati, Ohio, 45267-0595, United States

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Cleveland, Ohio, 44106, United States

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Portland, Oregon, 97220, United States

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Hershey, Pennsylvania, 17033, United States

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Lancaster, Pennsylvania, 17604-3200, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Cranston, Rhode Island, 02920, United States

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Providence, Rhode Island, 02905, United States

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Germantown, Tennessee, 38138, United States

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Dallas, Texas, 75203, United States

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Dallas, Texas, 75235-9151, United States

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Fort Sam Houston, Texas, 78234-3879, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84121, United States

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White River Junction, Vermont, 05009-0001, United States

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Charlottesville, Virginia, 22902, United States

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Chesapeake, Virginia, 23320-1706, United States

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Falls Church, Virginia, 22042, United States

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Richmond, Virginia, 23249, United States

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Bellevue, Washington, 98004, United States

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Kirkland, Washington, 98034, United States

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Puyallup, Washington, 98372, United States

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Seattle, Washington, 98133, United States

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Seattle, Washington, 98195, United States

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Spokane, Washington, 99220-3649, United States

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Madison, Wisconsin, 53792, United States

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Cheyenne, Wyoming, 82001, United States

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Adelaide, 5000, Australia

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Brisbane, 4029, Australia

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Kingswood, Australia

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Melbourne, 3181, Australia

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Woolloongabba, 4102, Australia

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Edmonton, Alberta, T6G 2B7, Canada

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Downsview, Ontario, M3N 2V7, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Clichy, 92118, France

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Créteil, 94010, France

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La Tronche, 38700, France

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Marseille, 13285, France

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Nice, 06202, France

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Rennes, 35033, France

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Strasbourg, 67091, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 13353, Germany

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Düsseldorf, 40225, Germany

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Freiburg im Breisgau, 79106, Germany

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Hanover, 30625, Germany

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Homburg/saar, 66424, Germany

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Kiel, 24105, Germany

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Bergamo, 24128, Italy

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Bologna, 40138, Italy

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Milan, 20121, Italy

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Napoli, 80131, Italy

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Pavia, 27100, Italy

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Pisa, 56124, Italy

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Otahuhu, New Zealand

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Ponce, 00716, Puerto Rico

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San Juan, 00921-3200, Puerto Rico

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San Juan, 00936-5067, Puerto Rico

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Santurce, 00909, Puerto Rico

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Badalona, 08915, Spain

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Barakaldo, 48903, Spain

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Barcelona, 08003, Spain

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Barcelona, 08025, Spain

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Madrid, 08029, Spain

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Madrid, 28006, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Seville, 41013, Spain

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Valencia, 46014, Spain

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Related Publications (1)

• 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. doi: 10.1056/NEJMoa066403.

  PMID: 17625124 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 13, 2004
• Study Start: December 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: February 23, 2016
• Results First Posted: January 21, 2016

Record last verified: 2016-01

Locations

DE (6); US (88); CA (3); FR (9); IT (6); AU (5); NZ (1); PR (4); ES (10)