A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 HCV

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00627926
First received: February 22, 2008
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: Hepatitis C
Interventions: Biological: peginterferon alfa-2a
Drug: telaprevir
Drug: ribavirin
Other: placebo

  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
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Participant Flow:   Overall Study
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
STARTED     361     364     363  
COMPLETED     202     260     268  
NOT COMPLETED     159     104     95  
Adverse Event                 26                 37                 36  
Death                 1                 0                 0  
Lost to Follow-up                 4                 3                 4  
Withdrawal by Subject                 2                 1                 0  
Lack of Efficacy                 118                 40                 38  
noncompliance/other                 8                 23                 17  



  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
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
Total Total of all reporting groups

Baseline Measures
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48     Total  
Number of Participants  
[units: participants]
  361     364     363     1088  
Age  
[units: participants]
       
<=18 years     1     0     0     1  
Between 18 and 65 years     357     359     353     1069  
>=65 years     3     5     10     18  
Age  
[units: years]
Mean ± Standard Deviation
  46.8  ± 10.0     47.0  ± 10.9     46.5  ± 10.8     46.8  ± 10.6  
Gender  
[units: participants]
       
Female     150     153     149     452  
Male     211     211     214     636  
Region of Enrollment  
[units: participants]
       
North America     214     227     214     655  
Europe     106     100     104     310  
Argentina     8     6     3     17  
Australia     14     14     18     46  
Israel     19     17     24     60  



  Outcome Measures
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1.  Primary:   Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment   [ Time Frame: 24 weeks after last dose of study treatment ]

Measure Type Primary
Measure Title Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment
Measure Description No text entered.
Time Frame 24 weeks after last dose of study treatment  
Safety Issue No  

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.
subjects who received at least 1 dose

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Measured Values
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment  
[units: participants]
     
SVR24 (statistical analysis 1 & 2)     158     250     271  
SVR24 (statistical analysis 3 & 4)     166     261     285  


Statistical Analysis 1 for Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 24.9
95% Confidence Interval ( 17.9 to 31.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR24 was defined as undetectable HCV RNA 24 weeks after the last planned dose of study treatment.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Treatment difference is estimated by the confidence interval.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 30.9
95% Confidence Interval ( 24.1 to 37.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR24 was defined as undetectable HCV RNA 24 weeks after the last planned dose of study treatment.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 25.7
95% Confidence Interval ( 18.8 to 32.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Treatment difference is estimated by the confidence interval.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 32.5
95% Confidence Interval ( 25.9 to 39.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Treatment differenceis estimated by the confidence interval.
[3] Other relevant estimation information:
  No text entered.



2.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA at Week 72   [ Time Frame: 24 weeks after last planned dose for subjects with a planned treatment duration of 48 weeks, and 48 weeks after last planned dose for subjects with a planned treatment duration of 24 weeks ]

Measure Type Secondary
Measure Title Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
Measure Description No text entered.
Time Frame 24 weeks after last planned dose for subjects with a planned treatment duration of 48 weeks, and 48 weeks after last planned dose for subjects with a planned treatment duration of 24 weeks  
Safety Issue No  

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.
subjects who received at least 1 dose

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Measured Values
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Proportion of Subjects Who Have Undetectable HCV RNA at Week 72  
[units: participants]
  158     243     265  


Statistical Analysis 1 for Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in Proportions [3] 23.0
95% Confidence Interval ( 15.9 to 30.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  with treatment, genotype, and baseline HCV RNA plasma level as factors
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in Proportions [3] 29.2
95% Confidence Interval ( 22.4 to 36.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  with treatment, genotype, and baseline HCV RNA plasma level as factors
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



3.  Secondary:   Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment   [ Time Frame: 4 weeks after starting study treatment ]

Measure Type Secondary
Measure Title Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Measure Description No text entered.
Time Frame 4 weeks after starting study treatment  
Safety Issue No  

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.
subjects who received at least 1 dose

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Measured Values
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment  
[units: participants]
  34     242     246  


Statistical Analysis 1 for Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 57.1
95% Confidence Interval ( 51.4 to 62.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 58.4
95% Confidence Interval ( 52.7 to 64.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



4.  Secondary:   Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12   [ Time Frame: Week 4 and Week 12 ]

Measure Type Secondary
Measure Title Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Measure Description No text entered.
Time Frame Week 4 and Week 12  
Safety Issue No  

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.
subjects who received at least 1 dose

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Measured Values
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12  
[units: participants]
  29     207     212  


Statistical Analysis 1 for Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 48.8
95% Confidence Interval ( 43.0 to 54.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 50.4
95% Confidence Interval ( 44.6 to 56.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



5.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA at Week 12   [ Time Frame: Week 12 ]

Measure Type Secondary
Measure Title Proportion of Subjects Who Have Undetectable HCV RNA at Week 12
Measure Description No text entered.
Time Frame Week 12  
Safety Issue No  

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.
subjects who received at least 1 dose

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Measured Values
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Proportion of Subjects Who Have Undetectable HCV RNA at Week 12  
[units: participants]
  146     277     283  


Statistical Analysis 1 for Proportion of Subjects Who Have Undetectable HCV RNA at Week 12
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 35.7
95% Confidence Interval ( 29.0 to 42.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Subjects Who Have Undetectable HCV RNA at Week 12
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in proportions [3] 37.5
95% Confidence Interval ( 30.9 to 44.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



6.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT)   [ Time Frame: Week 24 or Week 48, depending on planned treatment duration ]

Measure Type Secondary
Measure Title Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT)
Measure Description No text entered.
Time Frame Week 24 or Week 48, depending on planned treatment duration  
Safety Issue No  

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.
subjects who received at least 1 dose

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Measured Values
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT)  
[units: participants]
  229     295     314  


Statistical Analysis 1 for Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT)
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in Proportions [3] 17.6
95% Confidence Interval ( 11.2 to 24.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT)
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in Proportions [3] 23.1
95% Confidence Interval ( 17.0 to 29.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



7.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned)   [ Time Frame: 12 weeks after last planned dose of study treatment ]

Measure Type Secondary
Measure Title Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned)
Measure Description No text entered.
Time Frame 12 weeks after last planned dose of study treatment  
Safety Issue No  

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.
subjects who received at least 1 dose

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Measured Values
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Number of Participants Analyzed  
[units: participants]
  361     364     363  
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned)  
[units: participants]
  161     255     275  


Statistical Analysis 1 for Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned)
Groups [1] Placebo12/PR48 vs. T8/Placebo4/PR24or48
Method [2] Confidence Interval
Difference in Proportions [3] 25.5
95% Confidence Interval ( 18.5 to 32.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned)
Groups [1] Placebo12/PR48 vs. T12/PR24or48
Method [2] Confidence Interval
Difference in Proportions [3] 31.2
95% Confidence Interval ( 24.4 to 37.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



8.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment (SVR24Actual)   [ Time Frame: 24 weeks after last actual dose of study treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Proportion of Subjects Who Relapse, Defined as Those Who Complete Treatment as Assigned, Have Undetectable HCV RNA at EOT, and Become HCV RNA Detectable During Antiviral Follow-up   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Proportion of Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Biochemical Response Including Transaminase Levels   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Noninvasive Markers of Fibrosis   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Total Fatigue Score From the Fatigue Severity Scale (FSS)   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


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
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Results Point of Contact:  
Name/Title: BOB KAUFFMAN (Senior Vice President and CMO)
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: Shelley George, M.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00627926     History of Changes
Other Study ID Numbers: VX07-950-108
Study First Received: February 22, 2008
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration