Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00336479
First received: June 9, 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: Telaprevir
Drug: Ribavirin
Drug: Peginterferon Alfa 2a
Other: 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
Pbo12/PR48 Placebo + Peg-IFN + RBV for 12 weeks, followed by Peg-IFN + RBV for 36 weeks
T12/PR48 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 36 weeks
T12/PR24 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 12 weeks
T12/PR12 Telaprevir + Peg-IFN + RBV for 12 weeks

Participant Flow:   Overall Study
    Pbo12/PR48     T12/PR48     T12/PR24     T12/PR12  
STARTED     75     79     79     17  
COMPLETED     38     54     53     13  
NOT COMPLETED     37     25     26     4  
Adverse Event                 8                 11                 18                 4  
Noncompliant                 1                 7                 3                 0  
Physician Decision                 2                 3                 1                 0  
Lost to Follow-up                 3                 2                 0                 0  
Withdrawal by Subject                 3                 2                 3                 0  
Other                 0                 0                 1                 0  
Virologic Stopping Rule                 20                 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 + RBV for 36 weeks
T12/PR48 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 36 weeks
T12/PR24 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 12 weeks
T12/PR12 Telaprevir + Peg-IFN + RBV for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Pbo12/PR48     T12/PR48     T12/PR24     T12/PR12     Total  
Number of Participants  
[units: participants]
  75     79     79     17     250  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     75     79     79     17     250  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.8  ± 8.7     48.7  ± 7.4     48.4  ± 7.6     49.1  ± 8.0     48.1  ± 7.9  
Gender  
[units: participants]
         
Female     32     31     25     5     93  
Male     43     48     54     12     157  
Region of Enrollment  
[units: participants]
         
North America     75     79     79     17     250  



  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 study drug dosing ]

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:   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

4.  Secondary:   Genotypic and Phenotypic Analyses of the NS3•4A HCV Region   [ Time Frame: Week 60 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  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


  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
No text entered.


  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.


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: NCT00336479     History of Changes
Other Study ID Numbers: VX05-950-104
Study First Received: June 9, 2006
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration