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)
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
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History