Trial Profile
A Phase III, Randomized, Open-label, Two-arm Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Hepatitis C, Genotype 1-Infected Subjects Who Failed to Respond to Previous IFN-based Therapy.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 24 Sep 2015
Price :
$35
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At a glance
- Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
- Indications Hepatitis C
- Focus Registrational; Therapeutic Use
- Acronyms CONCERTO-2
- 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.
- 01 Sep 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.