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An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

Trial Profile

An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2018

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At a glance

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

    • 07 Mar 2018 Results of pooled data from nine clinical trials, were published in the Clinical Pharmacokinetics.
    • 23 May 2016 Time frame of the primary end point changed from 12 weeks after the last actual dose of study drug to Post-treatment Day 1 to Post-treatment Week 12.
    • 25 Apr 2016 According to a Enanta Pharmaceuticals media release, the US FDA approved its supplemental NDA for the use of VIEKIRA PAK (ombitasvir/paritaprevir/ritonavir tablets) + dasabuvir tablets without ribavirin in patients with genotype 1b (GT1b) chronic hepatitis C virus infection and compensated cirrhosis (Child-Pugh A), based on the results of this study.

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