A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma HCV RNA Levels Did Not Respond to Therapy

This study has been completed.
Sponsor:
Collaborator:
Tibotec, Inc
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00535847
First received: September 25, 2007
Last updated: June 22, 2011
Last verified: June 2011
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: telaprevir
Drug: ribavirin
Drug: Peg-interferon Alfa-2a

  Participant Flow
  Hide Participant Flow

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
T12/PR48 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 36 weeks
Other Subjects in this arm were receiving Telaprevir + Peg-IFN + RBV for 12 weeks. Subjects with a partial response, viral breakthrough, or relapse in the parent study, and who discontinued treatment before Week 12, were included in the “Other” treatment group.

Participant Flow:   Overall Study
    T12/PR24     T12/PR48     Other  
STARTED     81     34     2  
COMPLETED     59     20     0  
NOT COMPLETED     22     14     2  
Adverse Event                 5                 3                 2  
OTHER: Noncompliance                 1                 1                 0  
Protocol-defined Virologic Stopping Rule                 16                 10                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
T12/PR48 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 36 weeks
Other Subjects in this arm were receiving Telaprevir + Peg-IFN + RBV for 12 weeks. Subjects with a partial response, viral breakthrough, or relapse in the parent study, and who discontinued treatment before Week 12, were included in the “Other” treatment group.
Total Total of all reporting groups

Baseline Measures
    T12/PR24     T12/PR48     Other     Total  
Number of Participants  
[units: participants]
  81     34     2     117  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     81     34     2     117  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  50.0  ± 7.7     51.2  ± 5.9     49.0  ± 0.0     50.3  ± 7.2  
Gender  
[units: participants]
       
Female     28     8     0     36  
Male     53     26     2     81  
Region of Enrollment  
[units: participants]
       
North America     64     26     2     92  
Europe     17     8     0     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Subjects With Undetectable HCV RNA   [ Time Frame: 24 weeks after the completion of treatment ]

2.  Secondary:   Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse   [ Time Frame: 24 weeks after the completion of treatment ]

3.  Secondary:   Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse   [ Time Frame: at the end of treatment ]

4.  Secondary:   Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse   [ Time Frame: 48 weeks after completion of treatment ]

5.  Secondary:   Cross Tabulation of eRVR and SVR Responses in Study 107 With Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse   [ Time Frame: throughout study ]

6.  Primary:   Adverse Events and Clinical Laboratory Assessments   [ Time Frame: Week 48 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


Responsible Party: Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00535847     History of Changes
Other Study ID Numbers: VX06-950-107
Study First Received: September 25, 2007
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency