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A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)

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Trial Profile

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2019

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At a glance

  • Drugs Glecaprevir/pibrentasvir (Primary) ; Ombitasvir/paritaprevir/ritonavir
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms CERTAIN-1
  • Sponsors AbbVie

    • Most Recent Events

    • 12 Sep 2019 Results characterizing the pharmacokinetics of Glecaprevir/pibrentasvir in HCV-infected Japanese patients using data from CERTAIN 1 and 2 trials published in the Journal of Clinical Pharmacology
    • 27 Nov 2017 Results of a pooled efficacy and resistance analysis of the CERTAIN-1 and CERTAIN-2 studies, published in the Antimicrobial Agents and Chemotherapy
    • 24 Oct 2017 Results of pooled analysis of two phase III studies (CERTAIN I and CERTAIN II) assessing effect of Glecaprevir/pibrentasvir regimen on quality of life presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases.

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