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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00077636




Registration number
NCT00077636
Ethics application status
Date submitted
10/02/2004
Date registered
13/02/2004
Date last updated
23/02/2016

Titles & IDs
Public 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.
Scientific 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
Secondary ID [1] 0 0
NV17317
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Copegus
Treatment: Drugs - Copegus
Treatment: Drugs - peginterferon alfa-2a [Pegasys]
Treatment: Drugs - peginterferon alfa-2a [Pegasys]

Experimental: 1 -

Experimental: 2 -


Treatment: Drugs: Copegus
400mg po bid for 16 weeks

Treatment: Drugs: Copegus
400mg po bid for 24 weeks

Treatment: Drugs: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 16 weeks

Treatment: Drugs: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virological Response (SVR)
Timepoint [1] 0 0
Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
Secondary outcome [1] 0 0
Percentage of Participants With Virological Response at The End of Study Treatment
Timepoint [1] 0 0
Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
Secondary outcome [2] 0 0
Percentage of Participants Virological Response 12 Weeks Post-Treatment
Timepoint [2] 0 0
Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)
Secondary outcome [3] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to Week 40 and Week 48
Secondary outcome [4] 0 0
Percentage of Participants With Marked Laboratory Abnormalities
Timepoint [4] 0 0
Up to Week 40 and Week 48
Secondary outcome [5] 0 0
Participants With Marked Abnormal Vital Signs
Timepoint [5] 0 0
Up to Week 40 and Week 48
Secondary outcome [6] 0 0
Number of Participants With Highest Triglyceride Level
Timepoint [6] 0 0
Up to Week 40 and Week 48

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
1469
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Kingswood
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
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United States of America
State/province [12] 0 0
Illinois
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United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
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Minnesota
Country [20] 0 0
United States of America
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Missouri
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
Country [25] 0 0
United States of America
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Oregon
Country [26] 0 0
United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Vermont
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United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
United States of America
State/province [35] 0 0
Wyoming
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
France
State/province [38] 0 0
Clichy
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France
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Creteil
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France
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La Tronche
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France
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Marseille
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France
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Nice
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France
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Rennes
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France
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Strasbourg
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France
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Toulouse
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France
State/province [46] 0 0
Vandoeuvre-les-nancy
Country [47] 0 0
Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Homburg/saar
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Germany
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Kiel
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Milano
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Pisa
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New Zealand
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Otahuhu
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Puerto Rico
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Santurce
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Spain
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Badalona
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Spain
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Barakaldo
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00077636