Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00372385
First received: September 1, 2006
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: Chronic Hepatitis C
Interventions: Drug: Ribavirin
Drug: Peginterferon Alfa 2a
Drug: Placebo
Drug: Telaprevir

  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
Pbo12/PR48 Placebo + Peg-IFN + RBV for 12 weeks, followed by Peg-IFN and RBV for 36 weeks
T12/PR24 Peg-IFN + RBV for 12 weeks followed by Telaprevir + Peg-IFN + RBV for 12 weeks
T12/PR12 Telaprevir + Peg-IFN + RBV for 12 weeks
T12/P12 Telaprevir + Peg-IFN for 12 weeks

Participant Flow:   Overall Study
    Pbo12/PR48     T12/PR24     T12/PR12     T12/P12  
STARTED     82     81     82     78  
COMPLETED     49     61     72     70  
NOT COMPLETED     33     20     10     8  
Adverse Event                 6                 11                 9                 7  
Other Reason: Noncompliance                 0                 1                 1                 1  
Physician Decision                 1                 0                 0                 0  
Lost to Follow-up                 2                 0                 0                 0  
Withdrawal by Subject                 2                 1                 0                 0  
Other reasons for discontinuation were r                 5                 7                 0                 0  
Virologic Stopping Rule                 17                 0                 0                 0  



  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
Pbo12/PR48 Placebo + Peg-IFN + RBV for 12 weeks, followed by Peg-IFN and RBV for 36 weeks
T12/PR24 Peg-IFN + RBV for 12 weeks followed by Telaprevir + Peg-IFN + RBV for 12 weeks
T12/PR12 Telaprevir + Peg-IFN + RBV for 12 weeks
T12/P12 Telaprevir + Peg-IFN for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Pbo12/PR48     T12/PR24     T12/PR12     T12/P12     Total  
Number of Participants  
[units: participants]
  82     81     82     78     323  
Age  
[units: participants]
         
<=18 years     1     0     0     0     1  
Between 18 and 65 years     81     80     81     78     320  
>=65 years     0     1     1     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  44.4  ± 10.6     44.3  ± 10.0     44.1  ± 10.2     44.3  ± 10.8     44.3  ± 10.3  
Gender  
[units: participants]
         
Female     36     27     33     35     131  
Male     46     54     49     43     192  
Region of Enrollment  
[units: participants]
         
Europe     82     81     82     78     323  



  Outcome Measures
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1.  Primary:   Proportion of Subjects in Each Group With Undetectable Plasma HCV RNA, 24 Weeks After the Completion of the Assigned Study Drug Regimen   [ Time Frame: 24 weeks after the completion of the assigned study drug regimen ]

2.  Secondary:   Proportion of Subjects in Each Group With Undetectable Plasma HCV RNA, 12 Weeks After the Completion of the Assigned Study Drug Regimen   [ Time Frame: 12 weeks after the completion of the assigned study drug regimen ]

3.  Secondary:   Proportion of Subjects in Each of the Dose Groups B, C and D Who Received VX-950 With Undetectable Plasma HCV RNA at the Completion of the Study Drug Regimen   [ Time Frame: Week 12, Week 24, Week 48 ]

4.  Secondary:   Adverse Events and Clinical Laboratory Assessments, Including ALT and Other Liver Function Tests   [ Time Frame: Week 48 ]
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: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Pharmacokinetic Assessments of Telaprevir, Peginterferon Alfa-2a, and Ribavirin   [ Time Frame: Week 12 ]
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: NCT00372385     History of Changes
Other Study ID Numbers: VX05-950-104EU
Study First Received: September 1, 2006
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Agency for Health and Food Safety
United Kingdom: Medicines and Healthcare Products Regulatory Agency