A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin.

Trial Profile

A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin.

Completed
Phase of Trial: Phase II

Latest Information Update: 02 Apr 2014

At a glance

  • Drugs Peginterferon alfa-2a (Primary) ; Simeprevir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Acronyms OPERA-1
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 01 Oct 2010 According to a Medivir media release, the results of this trial will be presented at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
    • 01 Jun 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 01 Jun 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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