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

This study has been completed.
Sponsor:
Collaborator:
Tibotec, Inc
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00535847
First received: September 25, 2007
Last updated: July 9, 2014
Last verified: July 2014
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated interferon alfa 2a

  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
Subjects randomized to placebo control group in parent studies VX05-950-104 (NCT00336479), VX05-950-104EU (NCT00372385) and VX06-950-106 (NCT00420784) who had discontinued treatment in the parent study due to an inadequate response to treatment or relapsed after treatment were eligible to participate in this study VX06-950-107 (NCT00535847).

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
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Other Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.

Participant Flow:   Overall Study
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week     Other  
STARTED     81     34     2  
COMPLETED     59     20     0  
NOT COMPLETED     22     14     2  
Adverse Event                 5                 3                 2  
Non compliance                 1                 1                 0  
Protocol-defined Virologic Stopping Rule                 16                 10                 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.
The full analysis (FA) set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).

Reporting Groups
  Description
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Other Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Total Total of all reporting groups

Baseline Measures
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week     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
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1.  Primary:   Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment   [ Time Frame: 24 weeks after the completion of treatment (up to Week 72) ]

2.  Primary:   Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline through Week 48 ]

3.  Secondary:   Percentage of Prior Relapsers With Undetectable HCV RNA   [ Time Frame: 24 weeks after the completion of treatment (up to Week 72) ]

4.  Secondary:   Percentage of Subjects With End of Treatment Response   [ Time Frame: End of treatment (up to Week 48) ]

5.  Secondary:   Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment   [ Time Frame: 48 weeks after completion of treatment (up to Week 96) ]

6.  Secondary:   Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response   [ Time Frame: Baseline up to Week 72 ]


  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
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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 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: Jeff Chodakewitz, M.D.
Organization: Vertex Pharmaceuticals Incorporated
phone: 617-341-6777
e-mail: Jeff_Chodakewitz@vrtx.com


No publications provided


Responsible Party: 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: July 9, 2014
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