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| Descriptive Information Fields | |||||
| Brief Title † | A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C | ||||
| Official Title † | A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy | ||||
| Brief Summary | The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with peginterferon alfa-2a (Pegasys®), and ribavirin (Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Undetectable HCV RNA [ Time Frame: at end of treatment ] [ Designated as safety issue: No ] Undetectable HCV RNA [ Time Frame: 48 weeks after completion of treatment (Groups B, C, and D) ] [ Designated as safety issue: No ] Adverse events and clinical laboratory assessments, including ALT and other liver function tests. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ] Genotypic and phenotypic analyses of the NS3•4A HCV region. [ Time Frame: throughout study ] [ Designated as safety issue: No ] Pharmacokinetic assessments of telaprevir, Peg-IFN-a-2a, and RBV. [ Time Frame: throughout study ] [ Designated as safety issue: No ] |
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| Condition † | Hepatitis C | ||||
| Intervention † | Drug: Telaprevir Drug: Ribavirin Drug: Peg-interferon Alfa-2a |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 440 | ||||
| Start Date † | January 2007 | ||||
| Completion Date | May 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Canada, Germany, Netherlands, Puerto Rico | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00420784 | ||||
| Organization ID | VX06-950-106 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Vertex Pharmaceuticals Incorporated | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Vertex Pharmaceuticals Incorporated | ||||
| Verification Date | January 2008 | ||||
| First Received Date † | January 8, 2007 | ||||
| Last Updated Date | January 16, 2008 | ||||