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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00336479
First received: June 9, 2006
Last updated: June 25, 2014
Last verified: June 2014
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: Pegylated Interferon 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
A total of 263 subjects were enrolled, of which 13 subjects discontinued the study prior to study drug administration. A total of 250 subjects started treatment.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir tablet orally 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 48 weeks.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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.
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 24 weeks.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.

Participant Flow:   Overall Study
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week     Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week  
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  
Unspecified                 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.
The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.

Reporting Groups
  Description
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir tablet orally 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 48 weeks.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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.
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 24 weeks.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week     Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week     Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week     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:   Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing   [ Time Frame: 24 weeks after the completion of study drug dosing (up to Week 72) ]

2.  Secondary:   Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing   [ Time Frame: 12 weeks after the completion of study drug dosing (up to Week 60) ]

3.  Secondary:   Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Week 48 ]

4.  Secondary:   Number of Subjects With Viral Relapse   [ Time Frame: After last dose of study drug up to antiviral follow-up (up to Week 72) ]

5.  Secondary:   Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir   [ Time Frame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85 ]


  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 by Vertex Pharmaceuticals Incorporated

Publications automatically indexed to this study:

Responsible Party: 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 25, 2014
Health Authority: United States: Food and Drug Administration