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Trial information
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.
Status: Completed
Protocol number: NV17317
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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.
Target sample size is 1400.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. SVR Time frame: 24 weeks post-treatment (ie week 40 or week 48)
Key secondary outcomes: 1. Virological response Time frame: End of treatment (ie week 16 or week 24)
2. Virological response Time frame: 12 weeks post-treatment (ie week 28 or week 36)
3. AEs, laboratory parameters, vital signs. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:Australia - Adelaide
- Brisbane
- Kingswood
- Melbourne
- Woolloongabba
Canada - Edmonton, AB
- Downsview, ON
- Mississauga, ON
France - Clichy
- Creteil
- Grenoble
- Marseille
- Nice
- Rennes
- Strasbourg
- Toulouse
- Vandoeuvre-Les-Nancy
Germany - Berlin
- Düsseldorf
- Freiburg
- Hannover
- Homburg
- Kiel
Italy - Bergamo
- Bologna
- Milano
- Napoli
- Pavia
- Pisa
New Zealand Spain - Badalona
- Barcelona
- Bilbao
- Madrid
- Sevilla
- Valencia
United States - Birmingham, AL
- Mobile, AL
- Anchorage, AK
- Phoenix, AZ
- Scottsdale, AZ
- Little Rock, AR
- La Jolla, CA
- Long Beach, CA
- Los Angeles, CA
- Palo Alto, CA
- Sacramento, CA
- San Diego , CA
- San Francisco, CA
- San Luis Obispo, CA
- Littleton, CO
- Farmington, CT
- Gainesville, FL
- Jacksonville, FL
- Miami, FL
- Orlando, FL
- Pensacola, FL
- Sarasota , FL
- Tampa, FL
- Wellington, FL
- Atlanta, GA
- Austell, GA
- Honolulu, HI
- Boise, ID
- Indianapolis , IN
- Iowa City, IA
- Baton Rouge, LA
- New Orleans, LA
- Baltimore, MD
- Boston, MA
- Burlington, MA
- Worcester, MA
- Ann Arbor, MI
- Detroit, MI
- Minneapolis, MN
- Plymouth, MN
- St Louis, MO
- Albuquerque, NM
- Bayside, NY
- Binghamton, NY
- Bronx, NY
- Manhasset, NY
- New York, NY
- Williamsville, NY
- Chapel Hill, NC
- Charlotte, NC
- Durham, NC
- Fayetteville, NC
- Cincinnati, OH
- Cleveland, OH
- Portland, OR
- Hershey, PA
- Lancaster, PA
- Ponce, PR
- San Juan, PR
- Santurce, PR
- Cranston, RI
- Providence, RI
- Germantown, TN
- Dallas, TX
- Fort Sam Houston, TX
- Houston, TX
- Salt Lake City, UT
- White River Junction, VT
- Charlottesville, VA
- Chesapeake, VA
- Falls Church, VA
- Richmond, VA
- Bellevue, WA
- Kirkland, WA
- Puyallup, WA
- Seattle, WA
- Spokane , WA
- Madison, WI
- Cheyenne, WY
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