Trial Profile
A Phase III, Open-Label Study in Japan to Assess the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2b and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2021
Price :
$35
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At a glance
- Drugs Simeprevir (Primary) ; Peginterferon alfa-2b; Ribavirin
- Indications Hepatitis C
- Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
- Acronyms CONCERTO-4
- Sponsors Janssen Pharmaceutical KK
- 06 Jun 2013 Data 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.
- 26 Mar 2012 Planned end date changed from 1 Dec 2012 to 1 Nov 2012 as reported by ClinicalTrials.gov.