A randomized study to evaluate the safety and efficacy of IDX719 in combinations with simeprevir and/or TMC647055/ritonavir with or without ribavirin for 12 weeks in subjects with chronic hepatitis C infection

Trial Profile

A randomized study to evaluate the safety and efficacy of IDX719 in combinations with simeprevir and/or TMC647055/ritonavir with or without ribavirin for 12 weeks in subjects with chronic hepatitis C infection

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2015

At a glance

  • Drugs Samatasvir (Primary) ; Simeprevir (Primary) ; TMC 647055 (Primary) ; Ribavirin; Ritonavir
  • Indications Hepatitis C
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms HELIX-1
  • Sponsors Idenix Pharmaceuticals; Merck Sharp & Dohme
  • Most Recent Events

    • 22 Apr 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
    • 02 Mar 2015 Study focus of therapeutic use was added to the protocol; in treatment table genotypes 1a, 1b and 4 were included and treatment arms changed from 3 to 8; primary endpoint time frame changed to 95, 66 and 16 weeks.
    • 02 Mar 2015 Planned End Date changed from 1 May 2015 to 1 Apr 2015 as reported by ClinicalTrials.gov
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