CLINICAL TRIALS PROFILE FOR TELAPREVIR
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505(b)(2) Clinical Trials for telaprevir
| 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 | >Sponsor | >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. |
| NCT00528528 ↗ | An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants | Completed | Tibotec BVBA | Phase 2 | 2007-10-01 | The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection. |
| NCT00535847 ↗ | A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy | Completed | Tibotec, Inc | Phase 2 | 2007-10-01 | To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for telaprevir
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