CLINICAL TRIALS PROFILE FOR INCIVEK
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505(b)(2) Clinical Trials for INCIVEK
Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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New Formulation | NCT01511432 ↗ | A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects | Completed | Vertex Pharmaceuticals Incorporated | Phase 1 | 2012-01-01 | The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets. |
>Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for INCIVEK
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT01355289 ↗ | Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501 | Completed | Eisai Inc. | Phase 2 | 2011-11-01 | To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment. |
NCT01459913 ↗ | Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype | Terminated | Vertex Pharmaceuticals Incorporated | Phase 3 | 2011-11-01 | The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver. |
NCT01511432 ↗ | A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects | Completed | Vertex Pharmaceuticals Incorporated | Phase 1 | 2012-01-01 | The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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