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A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

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ClinicalTrials.gov Identifier: NCT00703118
Recruitment Status : Completed
First Posted : June 23, 2008
Results First Posted : August 11, 2011
Last Update Posted : January 22, 2014
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Tibotec BVBA

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Telaprevir
Drug: Peg-IFN-alfa-2a
Drug: Ribavirin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 105 sites in 17 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, United Kingdom, Israel, Italy, Netherlands, Poland, Sweden, and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
662 participants were treated (266 participants in the T12/PR48 group, 264 participants in the T12(DS)/PR48 group, and 132 participants in the Pbo/PR48 group) in this study.

Reporting Groups
  Description
T12/PR48 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
T12(DS)/PR48 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Pbo/PR48 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses

Participant Flow:   Overall Study
    T12/PR48   T12(DS)/PR48   Pbo/PR48
STARTED   266   264   132 
COMPLETED   245   248   110 
NOT COMPLETED   21   16   22 
Adverse Event                1                2                2 
Subject Ineligible To Continue The Trial                6                3                2 
Lost to Follow-up                6                4                4 
Withdrawal by Subject                8                7                13 
Not specified                0                0                1 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned   [ Time Frame: Week 72 ]

2.  Secondary:   Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4   [ Time Frame: Week 4 ]

3.  Secondary:   Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)   [ Time Frame: Week 48 ]

4.  Secondary:   Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned   [ Time Frame: Week 60 ]

5.  Secondary:   Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8   [ Time Frame: Week 4, Week 6, or Week 8 ]

6.  Secondary:   Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)   [ Time Frame: Up to Week 72 ]

7.  Secondary:   Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4   [ Time Frame: Baseline (Day 1) to Week 4 ]

8.  Secondary:   Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12   [ Time Frame: Week 4 and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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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  More Information