An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)

Trial Profile

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)

Completed
Phase of Trial: Phase II

Latest Information Update: 15 Mar 2018

At a glance

  • Drugs Glecaprevir (Primary) ; Pibrentasvir (Primary)
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms SURVEYOR-I
  • Sponsors AbbVie
  • Most Recent Events

    • 15 Mar 2018 Results (n=2041) of integrated efficacy analysis from EXPEDITION-2, EXPEDITION-4, ENDURANCE 1, 2, 3 and 4, SURVEYOR-I Part 2, SURVEYOR-II Parts 1 and 2, and SURVEYOR-II Part 4 studies published in the Journal of Hepatology
    • 28 Jul 2017 According to an Enanta Pharmaceuticals media release, the 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.
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