A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)
Phase of Trial: Phase III
Latest Information Update: 20 Oct 2017
At a glance
- Drugs Glecaprevir/pibrentasvir (Primary)
- Indications Hepatitis C
- Focus Registrational; Therapeutic Use
- Acronyms EXPEDITION-4
- Sponsors AbbVie
- 12 Oct 2017 Results assessing efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic renal impairment, were published in the New England Journal of Medicine.
- 28 Jul 2017 According to an Enanta Pharmaceuticals media release, European Commission (EC) granted AbbVie marketing authorization for MAVIRET (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). The approval of MAVIRET is supported by data from eight registrational studies in AbbVie's clinical development program.
- 23 Jun 2017 According to an Enanta Pharmaceuticals media release, the MAA evaluation is conducted under the European Union's centralized licensing procedure, and if approved will result in a marketing authorization valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History