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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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.
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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
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Secondary ID [1]
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NV17317
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virological Response (SVR)
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Assessment method [1]
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SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.
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Timepoint [1]
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Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
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Secondary outcome [1]
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Percentage of Participants With Virological Response at The End of Study Treatment
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Assessment method [1]
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Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.
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Timepoint [1]
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Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
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Secondary outcome [2]
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Percentage of Participants Virological Response 12 Weeks Post-Treatment
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Assessment method [2]
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Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.
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Timepoint [2]
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Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)
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Secondary outcome [3]
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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [3]
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An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
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Timepoint [3]
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Up to Week 40 and Week 48
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Secondary outcome [4]
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Percentage of Participants With Marked Laboratory Abnormalities
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Assessment method [4]
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Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 µmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 µmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 µmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.
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Timepoint [4]
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Up to Week 40 and Week 48
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Secondary outcome [5]
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Participants With Marked Abnormal Vital Signs
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Assessment method [5]
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Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
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Timepoint [5]
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Up to Week 40 and Week 48
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Secondary outcome [6]
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Number of Participants With Highest Triglyceride Level
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Assessment method [6]
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Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.
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Timepoint [6]
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Up to Week 40 and Week 48
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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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2006
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Sample size
Target
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Accrual to date
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Final
1469
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Recruitment in Australia
Recruitment state(s)
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- Adelaide
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- Brisbane
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- Kingswood
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- Melbourne
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- Woolloongabba
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5000 - Adelaide
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4029 - Brisbane
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Recruitment postcode(s) [3]
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- Kingswood
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3181 - Melbourne
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00077636
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Trial related presentations / publications
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Contacts
Principal investigator
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00077636
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