A Randomized, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2)

Trial Profile

A Randomized, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2)

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2017

At a glance

  • Drugs Glecaprevir/pibrentasvir (Primary) ; Ribavirin; Sofosbuvir
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms CERTAIN-2
  • Sponsors AbbVie
  • Most Recent Events

    • 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.
    • 11 May 2017 Status changed from active, no longer recruiting to completed.
    • 14 Mar 2017 According to an AbbVie media release, priority review has been granted by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the ribavirin-free regimen of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes (GT1-6) of the chronic hepatitis C virus (HCV). The New Drug Application (NDA) was supported by data from the Phase 3 CERTAIN studies in Japanese patients.
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