Status:
COMPLETED
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.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 recei...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
1469 Patients enrolled
Trial Details
Trial ID
NCT00077636
Start Date
December 1 2003
End Date
March 1 2006
Last Update
February 23 2016
Active Locations (132)
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1
Birmingham, Alabama, United States, 35294
2
Mobile, Alabama, United States, 36693
3
Anchorage, Alaska, United States, 99508
4
Phoenix, Arizona, United States, 85006