VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

Phase 3 Completed 90 enrolled Janssen Infectious Diseases BVBA Vertex Pharmaceuticals Incorporated · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

Timeline

Start: 2010-04
Primary completion: 2012-03
Completion: 2012-05

Publications

Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telaprevir	Small molecule	750 mg	Oral
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	1000 mg	Oral
Background	Ribavirin	Small molecule	1200 mg	Oral

VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

Summary

Timeline

Publications

Drugs

Indications