Clinical trial NCT00077636: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-02-13
Enrollment: 1469
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response (SVR)
timeFrame: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
Secondary outcomes:
measure: Percentage of Participants With Virological Response at The End of Study Treatment
timeFrame: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
measure: Percentage of Participants Virological Response 12 Weeks Post-Treatment
timeFrame: Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 40 and Week 48
measure: Percentage of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 40 and Week 48
measure: Participants With Marked Abnormal Vital Signs
timeFrame: Up to Week 40 and Week 48
measure: Number of Participants With Highest Triglyceride Level
timeFrame: Up to Week 40 and Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Littleton
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Austell
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Moline
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Baton Rouge
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Plymouth
country: United States
state: Minnesota
city: St Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Bayside
country: United States
state: New York
city: Binghamton
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Cranston
country: United States
state: Rhode Island
city: Providence
country: United States
state: Rhode Island
city: Germantown
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Sam Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: White River Junction
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Falls Church
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
city: Puyallup
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Cheyenne
country: United States
state: Wyoming
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Kingswood
country: Australia
city: Melbourne
country: Australia
city: Woolloongabba
country: Australia
city: Edmonton
country: Canada
state: Alberta
city: Downsview
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Clichy
country: France
city: Creteil
country: France
city: La Tronche
country: France
city: Marseille
country: France
city: Nice
country: France
city: Rennes
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Freiburg
country: Germany
city: Hannover
country: Germany
city: Homburg/saar
country: Germany
city: Kiel
country: Germany
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Otahuhu
country: New Zealand
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Santurce
country: Puerto Rico
city: Badalona
country: Spain
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.