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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

This study has been completed.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier:
NCT01241760
First received: October 28, 2010
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: September 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Genotype 1 Chronic Hepatitis C
Treatment Naive
Interventions: Drug: Ribavirin
Drug: Telaprevir
Drug: Pegylated interferon alfa-2a

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study evaluated the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with pegylated interferon and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was conducted between 15 November 2010 and 02 August 2012 and recruited participants from 125 study centers in 14 countries worldwide. 744 participants were initially enrolled and 740 out of them randomly allocated to the 2 treatment arms.

Reporting Groups
  Description
T12(q8h)/PR Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
T12(b.i.d.)/PR Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Participant Flow:   Overall Study
    T12(q8h)/PR   T12(b.i.d.)/PR
STARTED   371   369 
COMPLETED   337   329 
NOT COMPLETED   34   40 
Adverse Event                1                0 
Lost to Follow-up                18                22 
Withdrawal by Subject                13                13 
Switch To Commercially Available Medicat                1                4 
Not specified                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
T12(q8h)/PR Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
T12(b.i.d.)/PR Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Total Total of all reporting groups

Baseline Measures
   T12(q8h)/PR   T12(b.i.d.)/PR   Total 
Overall Participants Analyzed 
[Units: Participants]
 371   369   740 
Age 
[Units: Participants]
     
<=18 years   3   0   3 
Between 18 and 65 years   351   362   713 
>=65 years   17   7   24 
Age 
[Units: Years]
Mean (Full Range)
 48 
 (18 to 70) 
 47.5 
 (19 to 70) 
 47.7 
 (18 to 70) 
Gender 
[Units: Participants]
     
Female   136   160   296 
Male   235   209   444 
Region of Enrollment 
[Units: Participants]
     
Europe   192   179   371 
North-America   126   137   263 
Australia   28   28   56 
Mexico   5   4   9 
Brazil   20   21   41 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)   [ Time Frame: End of trial, 12 weeks after last planned dose ]

2.  Secondary:   Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)   [ Time Frame: End of trial, 24 weeks after last planned dose ]

3.  Secondary:   Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)   [ Time Frame: End of trial, 72 weeks after the start of study medication ]

4.  Secondary:   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.   [ Time Frame: Baseline, Week 4 and Week 4+12. ]

5.  Secondary:   Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs   [ Time Frame: Week 4, 12, 24, 32, 40 ]

6.  Secondary:   Percentage of Participants Who Relapsed During Follow-up Period   [ Time Frame: During Follow-Up (24 weeks after the last dose of study drug) ]

7.  Secondary:   Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)   [ Time Frame: End of trial, 12 weeks after the last planned dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Compound Development Team Leader
Organization: Janssen Infectious Diseases BVBA
phone: 32 14 64 13 70


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier: NCT01241760     History of Changes
Other Study ID Numbers: CR013711
OPTIMIZE-HCV ( Other Identifier: Janssen Infectious Diseases BVBA )
VX-950-C211 ( Other Identifier: Janssen Infectious Diseases BVBA )
2010-021628-84 ( EudraCT Number )
Study First Received: October 28, 2010
Results First Received: September 23, 2013
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration
USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board