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
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2003
End Date:March 2006

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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

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.


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.
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