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VX-950-TiDP24-C216: A Safety and Efficacy Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Tibotec BVBA
ClinicalTrials.gov Identifier:
NCT00703118
First received: June 19, 2008
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
Results First Received: July 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Placebo/ Standard Treatment (ST)/ Telaprevir
Drug: Placebo/ Standard Treatment (ST)
Drug: Telaprevir/Standard Treatment (ST)/Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
T12/PR48 12 weeks of 750 mg telaprevir q8h followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses
T12(DS)/PR48 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8h in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses
Pbo/PR48 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses

Participant Flow:   Overall Study
    T12/PR48     T12(DS)/PR48     Pbo/PR48  
STARTED     266     264     132  
COMPLETED     245     248     110  
NOT COMPLETED     21     16     22  
Adverse Event                 1                 2                 2  
Subject Ineligible To Continue The Trial                 6                 3                 2  
Lost to Follow-up                 6                 4                 4  
Withdrawal by Subject                 8                 7                 13  
Other                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
T12/PR48 12 weeks of 750 mg telaprevir q8h followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses
T12(DS)/PR48 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8h in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses
Pbo/PR48 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses
Total Total of all reporting groups

Baseline Measures
    T12/PR48     T12(DS)/PR48     Pbo/PR48     Total  
Number of Participants  
[units: participants]
 		  266     264     132     662  
Age  
[units: years]
Mean ± Standard Deviation 		  50.7  ± 8.51     51  ± 8.24     49.9  ± 9.74     50.6  ± 8.66  
Gender  
[units: participants]
 		       
Female     83     75     44     202  
Male     183     189     88     460  
AgeCategoricalOther  
[units: participants]
 		       
Missing     0     0     0     0  
<=18 years     0     0     0     0  
Between 18 and 65 years     258     253     123     634  
>= 65 years     8     11     9     28  
Region Enroll  
[units: participants]
 		       
EUROPE     127     139     73     339  
NORTH-AMERICA     89     72     39     200  
OTHER     50     53     20     123  



  Outcome Measures
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1.  Primary:   Sustained Virologic Response (SVR) in Prior Relapsers   [ Time Frame: Week 72 ]
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2.  Primary:   Sustained Virologic Response (SVR) in Prior Non-responders   [ Time Frame: Week 72 ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Medical Leader
Organization: Tibotec
phone: 1 609 730-3174


No publications provided by Tibotec BVBA

Publications automatically indexed to this study:


Responsible Party: Compound Development team Leader, Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00703118     History of Changes
Other Study ID Numbers: CR014842
Study First Received: June 19, 2008
Results First Received: July 18, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration
USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH