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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.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

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

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official title: A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-na´ve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: SVR

Secondary outcome:

Virological response

Virological response

AEs, laboratory parameters, vital signs.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


Locations and Contacts

Adelaide 5000, Australia

Brisbane 4029, Australia

Kingswood, Australia

Melbourne 3181, Australia

Woolloongabba 4102, Australia

Clichy 92118, France

Creteil 94010, France

La Tronche 38700, France

Marseille 13285, France

Nice 06202, France

Rennes 35033, France

Strasbourg 67091, France

Toulouse 31059, France

Vandoeuvre-les-nancy 54511, France

Berlin 13353, Germany

D├╝sseldorf 40225, Germany

Freiburg 79106, Germany

Hannover 30625, Germany

Homburg/saar 66424, Germany

Kiel 24105, Germany

Bergamo 24128, Italy

Bologna 40138, Italy

Milano 20121, Italy

Napoli 80131, Italy

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Badalona 08915, Spain

Barakaldo 48903, Spain

Barcelona 08003, Spain

Barcelona 08025, Spain

Madrid 08029, Spain

Madrid 28006, Spain

Madrid 28007, Spain

Madrid 28034, Spain

Sevilla 41013, Spain

Valencia 46014, Spain

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Additional Information

Starting date: December 2003
Last updated: August 17, 2015

Page last updated: August 23, 2015

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