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)

Trial Profile

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Glecaprevir/pibrentasvir (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms EXPEDITION-4
  • Sponsors AbbVie
  • Most Recent Events

    • 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.
    • 23 Jun 2017 According to an Enanta Pharmaceuticals media release, based on the data from SURVEYOR-I, SURVEYOR-II, EXPEDITION-4, ENDURANCE-1, ENDURANCE-2, ENDURANCE 3 and ENDURANCE-4 trials, the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET for treatment for adults with chronic hepatitis C virus infection. Final decision is expected in the third quarter of 2017.
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