A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00420784
First received: January 8, 2007
Last updated: June 22, 2011
Last verified: June 2011
Results First Received: June 22, 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
Interventions: Drug: Telaprevir
Drug: Ribavirin
Drug: Peg-interferon Alfa-2a
Drug: Matching 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
T12/PR24 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks
T24/PR48 Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
T24/P24 Telaprevir + Peg-IFN for 24 weeks
Pbo24/PR48 Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks

Participant Flow:   Overall Study
    T12/PR24     T24/PR48     T24/P24     Pbo24/PR48  
STARTED     115     113     111     114  
COMPLETED     86     55     58     36  
NOT COMPLETED     29     58     53     78  



  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.
No text entered.

Reporting Groups
  Description
T12/PR24 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks
T24/PR48 Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
T24/P24 Telaprevir + Peg-IFN for 24 weeks
Pbo24/PR48 Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
Total Total of all reporting groups

Baseline Measures
    T12/PR24     T24/PR48     T24/P24     Pbo24/PR48     Total  
Number of Participants  
[units: participants]
  115     113     111     114     453  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     114     111     108     113     446  
>=65 years     1     2     3     1     7  
Age  
[units: years]
Mean ± Standard Deviation
  49.7  ± 7.8     52.0  ± 5.5     51.9  ± 7.1     49.8  ± 7.2     50.8  ± 7.0  
Gender  
[units: participants]
         
Female     37     33     39     38     147  
Male     78     80     72     76     306  
Region of Enrollment  
[units: participants]
         
North America     101     103     101     101     406  
Europe     14     10     10     13     47  



  Outcome Measures
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1.  Primary:   Undetectable HCV RNA at 24 Weeks After the Completion of Treatment   [ Time Frame: 24 weeks after the end of treatment (after actual last dose) ]

2.  Secondary:   Undetectable HCV RNA   [ Time Frame: at the completion of treatment ]

3.  Secondary:   Undetectable HCV RNA   [ Time Frame: 48 weeks after completion of treatment ]

4.  Secondary:   Adverse Events and Clinical Laboratory Assessments, Including ALT and Other Liver Function Tests.   [ Time Frame: throughout study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Genotypic and Phenotypic Analyses of the NS3•4A HCV Region.   [ Time Frame: throughout study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Pharmacokinetic Assessments of Telaprevir, Peg-IFN-a-2a, and RBV.   [ Time Frame: Week 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Robert Kauffman, M.D., Ph.D.
Organization: Vertex Pharmaceuticals Incorporated
phone: 617-444-6158
e-mail: Robert_Kauffman@vrtx.com


No publications provided by Vertex Pharmaceuticals Incorporated

Publications automatically indexed to this study:

Responsible Party: Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00420784     History of Changes
Other Study ID Numbers: VX06-950-106
Study First Received: January 8, 2007
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)