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)

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Oct 2017

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

    • 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.
    • 24 Oct 2017 Results of pooled analysis of two phase III trials (CERTAIN I and CERTAIN II) assessing safety and efficacy presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 27 Sep 2017 According to an AbbVie media release, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved MAVIRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). Authorization is supported by data from the Phase 3 CERTAIN studies in Japanese patients and supplemented with registrational studies from AbbVie's global clinical development program for MAVIRET.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top