An Open-Label, Single-Arm Phase III Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Subjects.
Phase of Trial: Phase III
Latest Information Update: 29 Mar 2017
At a glance
- Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
- Indications Hepatitis C
- Focus Registrational; Therapeutic Use
- Acronyms RESTORE
- Sponsors Janssen R&D Ireland
- 10 Jun 2017 Biomarkers information updated
- 14 Apr 2014 According to the ClinicalTrials.gov record, status changed from active, no longer recruiting to completed.
- 24 Mar 2014 Results will be presented at The International Liver Congress of the European Association for the study of the Liver (EASL) according to a Medivir AB media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History