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. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 10, 2004

Last Updated Date

May 13, 2009

Start Date ^†

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00077636 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Efficacy: End-of-treatment virologic response, virologic response 12 weeks post- treatment Safety: Vital signs, laboratory tests, clinical adverse events

Descriptive Information

Brief Title ^†

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.

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hepatitis C, Chronic

Intervention ^†

Drug: peginterferon alfa-2a (40KD) [PEGASYS]
Drug: Copegus

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1469

Completion Date

March 2006

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Canada, France, Germany, Italy, New Zealand, Puerto Rico, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00077636

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.