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A Phase III, open-label trial of TMC435 in combination with peginterferon alpha-2a and ribavirin for HCV genotype-1 infected subjects who participated in the placebo group of a Phase II/III TMC435 study (C201, C205, C206, C208, C216 or HPC3007), or who received short-term (up to 14 days) direct-acting antiviral treatment for hepatitis C infection in a selected Tibotec-sponsored Phase I study.

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Trial Profile

A Phase III, open-label trial of TMC435 in combination with peginterferon alpha-2a and ribavirin for HCV genotype-1 infected subjects who participated in the placebo group of a Phase II/III TMC435 study (C201, C205, C206, C208, C216 or HPC3007), or who received short-term (up to 14 days) direct-acting antiviral treatment for hepatitis C infection in a selected Tibotec-sponsored Phase I study.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2021

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At a glance

  • Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen R&D Ireland

    • Most Recent Events

    • 07 Apr 2015 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.
    • 06 Mar 2014 Status changed from recruiting to active, no longer recruiting as reported by the ClinicalTrials.gov record.
    • 30 May 2013 Planned end date changed from 1 Jan 2015 to 1 Mar 2015 as reported by ClinicalTrials.gov record.
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