An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naive Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)

Trial Profile

An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naive Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)

Completed
Phase of Trial: Phase III

Latest Information Update: 04 May 2017

At a glance

  • Drugs Dasabuvir (Primary) ; Ombitasvir/paritaprevir/ritonavir (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms GARNET
  • Sponsors AbbVie
  • Most Recent Events

    • 27 Feb 2017 According to an Enanta Pharmaceuticals media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has granted a positive opinion for an eight-week treatment regimen of VIEKIRAX (ombitasvir/paritaprevir/ritonavir) + EXVIERA (dasabuvir) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic HCV infection and minimal to moderate fibrosis based on data from this trial.
    • 01 Dec 2016 Status changed from active, no longer recruiting to completed.
    • 31 Oct 2016 Planned End Date changed from 1 Oct 2016 to 1 Nov 2016.
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