Trial Profile
A Phase III, Randomized, Double-blind, Placebo-controlled Trial in Japan to Investigate the Efficacy and Safety 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.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Nov 2021
Price :
$35
*
At a glance
- Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
- Indications Hepatitis C
- Focus Registrational; Therapeutic Use
- Acronyms CONCERTO-1
- Sponsors Janssen Pharmaceutical KK
- 09 Apr 2014 Results published in the Journal of Hepatology.
- 06 Jun 2013 Results published in a Medivir AB media release and presented at the Japan Society of Hepatology's 49th Annual Meeting.
- 22 Feb 2013 Data from this trial will be used in support of regulatory filings with the Japanese authorities for the use of simeprevir + peginterferon alfa + ribavirin for genotype 1 hepatitis C according to a a Medivir AB media release.