A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)

Trial Profile

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)

Completed
Phase of Trial: Phase II/III

Latest Information Update: 04 Oct 2017

At a glance

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

    • 19 Sep 2017 Results (n=131) assessing safety and efficacy of ABT-493 and ABT-530 coadministered with and without ribavirin in adults with chronic hepatitis C virus (HCV) genotype 2,3, 4, 5 or 6 infection, were published in the 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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