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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 07 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.
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