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Last Updated: September 22, 2020

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CLINICAL TRIALS PROFILE FOR TELAPREVIR

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505(b)(2) Clinical Trials for telaprevir

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 telaprevir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00336479 Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C Completed Vertex Pharmaceuticals Incorporated Phase 2 2006-06-01 Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
NCT00372385 Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C Completed Vertex Pharmaceuticals Incorporated Phase 2 2006-08-01 Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
NCT00420784 A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3) Completed Vertex Pharmaceuticals Incorporated Phase 2 2007-02-01 The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
NCT00509210 Study of Telaprevir in Subjects With Hepatic Impairment Completed Vertex Pharmaceuticals Incorporated Phase 1 2007-09-01 The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for telaprevir

Condition Name

Condition Name for telaprevir
Intervention Trials
Hepatitis C 44
Hepatitis C, Chronic 15
Chronic Hepatitis C 10
HIV 7
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Condition MeSH

Condition MeSH for telaprevir
Intervention Trials
Hepatitis C 87
Hepatitis 77
Hepatitis A 55
Hepatitis C, Chronic 41
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Clinical Trial Locations for telaprevir

Trials by Country

Trials by Country for telaprevir
Location Trials
United States 449
Canada 44
Japan 42
Germany 26
Spain 21
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Trials by US State

Trials by US State for telaprevir
Location Trials
Texas 30
New York 26
Maryland 25
California 25
Florida 24
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Clinical Trial Progress for telaprevir

Clinical Trial Phase

Clinical Trial Phase for telaprevir
Clinical Trial Phase Trials
Phase 4 12
Phase 3 26
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for telaprevir
Clinical Trial Phase Trials
Completed 72
Terminated 11
Withdrawn 5
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Clinical Trial Sponsors for telaprevir

Sponsor Name

Sponsor Name for telaprevir
Sponsor Trials
Vertex Pharmaceuticals Incorporated 36
Tibotec BVBA 12
Tibotec Pharmaceutical Limited 6
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Sponsor Type

Sponsor Type for telaprevir
Sponsor Trials
Industry 102
Other 88
NIH 7
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