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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/NCT00627926
Registration number
NCT00627926
Ethics application status
Date submitted
22/02/2008
Date registered
4/03/2008
Date last updated
8/08/2014
Titles & IDs
Public title
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
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Scientific title
A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
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Secondary ID [1]
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VX07-950-108
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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
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0
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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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
Other interventions - Pegylated Interferon Alfa 2a
Treatment: Drugs - Telaprevir
Treatment: Drugs - Ribavirin
Other interventions - Placebo
Placebo Comparator: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week - Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Experimental: Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week - Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week - Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Other interventions: Pegylated Interferon Alfa 2a
subcutaneous injection, 180 micrograms once per week
Treatment: Drugs: Telaprevir
375 mg tablets administered orally every 8 hours at a dose of 750 mg
Treatment: Drugs: Ribavirin
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing =75 kg
Other interventions: Placebo
Telaprevir matching placebo
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
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Assessment method [1]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
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Timepoint [1]
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24 weeks after last planned dose of study treatment (up to Week 72)
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Secondary outcome [1]
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Number of Subjects With Undetectable HCV RNA at Week 72
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Assessment method [1]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
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Timepoint [1]
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Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)
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Secondary outcome [2]
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Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
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Assessment method [2]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.
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Timepoint [2]
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Week 4
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Secondary outcome [3]
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Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
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Assessment method [3]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.
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Timepoint [3]
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Week 4 and Week 12
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Secondary outcome [4]
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Number of Subjects With Undetectable HCV RNA at Week 12
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Assessment method [4]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
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Assessment method [5]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
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Timepoint [5]
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End of treatment (up to Week 48)
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Secondary outcome [6]
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Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
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Assessment method [6]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
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Timepoint [6]
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12 weeks after last planned dose of study treatment (up to Week 60)
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Secondary outcome [7]
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Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
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Assessment method [7]
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
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Timepoint [7]
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24 weeks after last actual dose of study treatment (up to Week 72)
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Secondary outcome [8]
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Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
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Assessment method [8]
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Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.
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Timepoint [8]
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After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
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Secondary outcome [9]
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Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
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Assessment method [9]
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Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.
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Timepoint [9]
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Baseline up to Week 48
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Secondary outcome [10]
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Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
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Assessment method [10]
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FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.
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Timepoint [10]
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Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)
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Secondary outcome [11]
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Fatigue Severity Scale (FSS) Total Score
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Assessment method [11]
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FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.
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Timepoint [11]
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Baseline, Week 4, 12, 24, 36, 48, 72
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Secondary outcome [12]
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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [12]
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AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
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Timepoint [12]
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Baseline up to Week 48
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Eligibility
Key inclusion criteria
Inclusion Criteria
- Has not received any previous treatment with any approved or investigational drug or
drug regimen for the treatment of hepatitis C
- Male and female subjects, 18 to 70 years of age, inclusive
- Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic
Acid (RNA)
- Screening laboratory values, tests, and physical exam within acceptable ranges
- Able and willing to follow contraception requirements
- Able to read and understand, and willing to sign the informed consent form and abide
by the study restrictions
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Minimum age
18
Years
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Maximum age
70
Years
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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
Exclusion Criteria
- Subject has any contraindications to Pegasys® or Copegus® therapy
- Evidence of hepatic decompensation in cirrhotic subjects
- History of organ transplant
- History of, or any current medical condition which could impact the safety of the
subject in participation in the study
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/03/2008
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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
1/05/2010
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Sample size
Target
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Accrual to date
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Final
1095
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Darlinghurst
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- Fitzroy
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- Greenslopes
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- Melbourne
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- Perth
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Recruitment hospital [6]
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- Westmead
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Recruitment hospital [7]
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- Woolloongabba
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Recruitment postcode(s) [1]
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- Darlinghurst
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- Fitzroy
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- Greenslopes
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- Melbourne
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- Perth
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- Westmead
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Recruitment postcode(s) [7]
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- Woolloongabba
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Recruitment outside Australia
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Alabama
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Valencia
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Glasgow
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Hampstead
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vertex Pharmaceuticals Incorporated
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Tibotec Pharmaceutical Limited
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in
combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00627926
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Vertex Pharmaceuticals Incorporated
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00627926
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