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Last Updated: January 21, 2020

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CLINICAL TRIALS PROFILE FOR INCIVEK

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505(b)(2) Clinical Trials for Incivek

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
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 >Phase >Start Date >Summary

All Clinical Trials for Incivek

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT01581138 VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C Completed Vertex Pharmaceuticals Incorporated Phase 2 2012-07-01 The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Incivek

Condition Name

Condition Name for Incivek
Intervention Trials
Hepatitis C 3
Chronic Hepatitis C 2
Hepatitis C, Chronic 2
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Condition MeSH

Condition MeSH for Incivek
Intervention Trials
Hepatitis C 10
Hepatitis 9
Hepatitis A 7
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Clinical Trial Locations for Incivek

Trials by Country

Trials by Country for Incivek
Location Trials
United States 58
Canada 8
Brazil 5
Austria 2
Poland 2
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Trials by US State

Trials by US State for Incivek
Location Trials
Texas 6
California 4
Alabama 3
Wisconsin 3
Virginia 3
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Clinical Trial Progress for Incivek

Clinical Trial Phase

Clinical Trial Phase for Incivek
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Incivek
Clinical Trial Phase Trials
Completed 4
Terminated 3
Unknown status 2
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Clinical Trial Sponsors for Incivek

Sponsor Name

Sponsor Name for Incivek
Sponsor Trials
Vertex Pharmaceuticals Incorporated 5
Santaris Pharma A/S 2
Louis Stokes VA Medical Center 1
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Sponsor Type

Sponsor Type for Incivek
Sponsor Trials
Industry 8
Other 4
U.S. Fed 1
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