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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
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Alabama
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Alaska
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Toulouse
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Berlin
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Kiel
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Napoli
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Pisa
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00077636
Trial related presentations / 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. doi: 10.1056/NEJMoa066403.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00077636