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.

This study has been completed.

First Received: February 10, 2004 Last Updated: May 13, 2009 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077636

Purpose

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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: Copegus	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferons

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

SVR [ Time Frame: 24 weeks post-treatment (ie week 40 or week 48) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Virological response [ Time Frame: End of treatment (ie week 16 or week 24) ] [ Designated as safety issue: No ]
Virological response [ Time Frame: 12 weeks post-treatment (ie week 28 or week 36) ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	1469
Study Completion Date:	March 2006

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 16 weeks Drug: Copegus 400mg po bid for 16 weeks
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 24 weeks Drug: Copegus 400mg po bid for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077636

Show 132 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV17317
Study First Received:	February 10, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077636 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 25, 2009