A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00420784
First received: January 8, 2007
Last updated: July 9, 2014
Last verified: July 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: Hepatitis C
Interventions: Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated Interferon Alfa 2a
Drug: Matching 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 465 subjects were enrolled, of which 12 subjects discontinued the study prior to study drug administration. A total of 453 subjects started treatment.

Reporting Groups
  Description
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir 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 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 24 Week+Peg-IFN-alfa-2a 24 Week Single loading dose of telaprevir 1125 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, for 24 weeks.
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.

Participant Flow:   Overall Study
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week     Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week     Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week     PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week  
STARTED     115     113     111     114  
COMPLETED     86     55     58     36  
NOT COMPLETED     29     58     53     78  
Adverse Event                 11                 29                 10                 5  
Withdrawal by Subject                 0                 1                 0                 0  
Lost to Follow-up                 0                 0                 2                 1  
Virologic Stopping Rule                 17                 26                 41                 67  
Unspecified                 1                 2                 0                 5  



  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.
Full Analysis Set = subjects who received at least 1 dose of study drug.

Reporting Groups
  Description
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir 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 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 24 Week+Peg-IFN-alfa-2a 24 Week Single loading dose of telaprevir 1125 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, for 24 weeks.
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Total Total of all reporting groups

Baseline Measures
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week     Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week     Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week     PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week     Total  
Number of Participants  
[units: participants]
  115     113     111     114     453  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     114     111     108     113     446  
>=65 years     1     2     3     1     7  
Age  
[units: years]
Mean ± Standard Deviation
  49.7  ± 7.8     52.0  ± 5.5     51.9  ± 7.1     49.8  ± 7.2     50.8  ± 7.0  
Gender  
[units: participants]
         
Female     37     33     39     38     147  
Male     78     80     72     76     306  
Region of Enrollment  
[units: participants]
         
North America     101     103     101     101     406  
Europe     14     10     10     13     47  



  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 Completion of Study Drug Dosing   [ Time Frame: Completion of study drug dosing (up to Week 48) ]

3.  Secondary:   Percentage of Subjects With Undetectable Plasma HCV RNA   [ Time Frame: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups) ]

4.  Secondary:   Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 2 weeks after last dose of study drug (up to Week 50) ]

5.  Secondary:   Number of Subjects With Viral Relapse   [ Time Frame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72) ]

6.  Secondary:   Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir   [ Time Frame: Week 2, 4, 8, 12, 16, 24 ]


  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: NCT00420784     History of Changes
Other Study ID Numbers: VX06-950-106
Study First Received: January 8, 2007
Results First Received: June 22, 2011
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)