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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/NCT01241760




Registration number
NCT01241760
Ethics application status
Date submitted
28/10/2010
Date registered
16/11/2010
Date last updated
4/06/2014

Titles & IDs
Public title
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
Scientific title
A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Secondary ID [1] 0 0
OPTIMIZE-HCV
Secondary ID [2] 0 0
CR013711
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genotype 1 Chronic Hepatitis C 0 0
Treatment Naive 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 - Ribavirin
Treatment: Drugs - Telaprevir
Treatment: Drugs - Pegylated interferon alfa-2a
Treatment: Drugs - Telaprevir

Experimental: 001 T(q8h) / PR - Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)

Experimental: 002 T(b.i.d.) / PR - Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)


Treatment: Drugs: Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4

Treatment: Drugs: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks

Treatment: Drugs: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4

Treatment: Drugs: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Timepoint [1] 0 0
End of trial, 12 weeks after last planned dose
Secondary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Timepoint [1] 0 0
End of trial, 24 weeks after last planned dose
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Timepoint [2] 0 0
End of trial, 72 weeks after the start of study medication
Secondary outcome [3] 0 0
Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Timepoint [3] 0 0
Baseline, Week 4 and Week 4+12.
Secondary outcome [4] 0 0
Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Timepoint [4] 0 0
Week 4, 12, 24, 32, 40
Secondary outcome [5] 0 0
Percentage of Participants Who Relapsed During Follow-up Period
Timepoint [5] 0 0
During Follow-Up (24 weeks after the last dose of study drug)
Secondary outcome [6] 0 0
Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Timepoint [6] 0 0
End of trial, 12 weeks after the last planned dose

Eligibility
Key inclusion criteria
- Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL

- Patients should not have had any previous treatment for hepatitis C

- Patient must have documentation of a liver biopsy within 2 years before the screening
visit or the patient must agree to have a biopsy performed within the screening period

- Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP
> 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening
period

- A female patient of childbearing potential and a nonvasectomized male patient who has
a female partner of childbearing potential must agree to the use of 2 effective
methods of birth control from screening until 6 months (female patient) or 7 months
(male patient) after the last dose of RBV.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or
patient is infected with more than one genotype subtype

- Patient has a pre-existing psychiatric condition

- Patient has history of decompensated liver disease or shows evidence of significant
liver disease in addition to hepatitis C

- Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection

- Patient has active malignant disease or history of malignant disease within the past 5
years (with the exception of treated basal cell carcinoma).

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 3
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
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
744
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Darlinghurst
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Greenslopes
Recruitment hospital [7] 0 0
- Melbourne
Recruitment hospital [8] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Greenslopes
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Louisiana
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Maryland
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Missouri
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Virginia
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Washington
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Austria
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Graz N/A
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Austria
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Linz
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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Campinas
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Brazil
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Salvador
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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France
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Clichy
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France
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Creteil
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France
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Grenoble
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France
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Lille
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France
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Lyon
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France
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Paris
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France
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Pessac
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France
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Vandoeuvre Les Nancy
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Mainz
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Germany
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Regensburg
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Ireland
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Dublin 9
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Ireland
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Dublin
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Mexico
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Mex Ctity
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Mexico
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Mexico
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Mexico
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Monterrey
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Poland
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Bialystok
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Bydgoszcz
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Poland
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Czeladz
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Warszawa
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Spain
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Barcelona N/A
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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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Malaga N/A
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Spain
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Santander N/A
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Spain
State/province [69] 0 0
Sevilla N/A
Country [70] 0 0
Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Malmö
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Sweden
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Stockholm
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United Kingdom
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Birmingham
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
State/province [78] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Infectious Diseases BVBA
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Vertex Pharmaceuticals Incorporated
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice
daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in
treatment-naïve participants with chronic HCV genotype 1 infection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01241760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Infectious Diseases BVBA Clinical Trial
Address 0 0
Janssen Infectious Diseases BVBA
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/ct2/show/NCT01241760