A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naive, Genotype 1 Hepatitis C-Infected Subjects
Phase of Trial: Phase III
Latest Information Update: 18 Jan 2016
At a glance
- Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
- Indications Hepatitis C
- Focus Registrational; Therapeutic Use
- Sponsors Janssen R&D Ireland
- 18 Jan 2016 Results published in the Journal of Gastroenterology and Hepatology
- 18 Jan 2016 Primary endpoint (SVR12) has been met as results published in the Journal of Gastroenterology and Hepatology.
- 16 Mar 2015 Results published in Medivir AB media release.