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)
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
- 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.