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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
History of Changes
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
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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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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 ]
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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 ]
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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 ]
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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 ]
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5.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA at Week 12   [ Time Frame: Week 12 ]
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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 ]
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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 ]
  Show Outcome Measure 7

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
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  Other Adverse Events
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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.


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