drugset / Trial / NCT01241760
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
Phase 3
Completed
744 enrolled
Janssen Infectious Diseases BVBA
Vertex Pharmaceuticals Incorporated · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.
Timeline
- Start
- 2010-12
- Primary completion
- 2012-08
- Completion
- 2012-11
Publications
- Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.
- Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telaprevir | Small molecule | 750 mg | Oral |
| Subject | Telaprevir | Small molecule | 1125 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 |