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A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects Who Have Failed Prior Treatment With Pegylated Interferon and Ribavirin (P/R) With Chronic HCV GT1, GT4, and GT6 Infection

Trial Profile

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects Who Have Failed Prior Treatment With Pegylated Interferon and Ribavirin (P/R) With Chronic HCV GT1, GT4, and GT6 Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2019

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At a glance

  • Drugs Elbasvir/grazoprevir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms C-EDGE TE; C-EDGE TREATMENT-EXPERIENCED
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 19 Feb 2019 Results of integrated analysis of data from 12 international phase 2/3 clinical trials(NCT01717326,NCT01932762,NCT02092350,NCT02105467,NCT02105662,NCT02105688,NCT02105701,NCT02115321,NCT02203149,NCT02251990,NCT02252016 and NCT02358044) assessing safety and efficacy of Elbasvir/Grazoprevir in Asian Participants with Hepatitis C Virus Genotypes 1 and 4 Infection published in the Journal of Gastroenterology and Hepatology
    • 26 Apr 2018 Results of retrospective analysis of black participants receiving elbasvir/grazoprevir (EBR/GZR) in nine phase 2/3 clinical trials (C-SURFER (NCT02092350); C-EDGE COINFECTION (NCT02105662) ; C-EDGE TREATMENT-NAIVE (NCT02105467/protocol PN060) ; C-EDGE TREATMENT-EXPERIENCED (NCT02105701/protocol PN068) ; C-WORTHY (NCT01717326/protocol PN035); C-EDGE IBLD (NCT02252016/protocol PN065), and C-EDGE COSTAR (NCT02105688/protocol PN062)) published in the American Journal of Gastroenterology
    • 14 Apr 2018 Results of an analysis assessing the effect of 12 week oral regimens of Elbasvir and Grazoprevir on health related quality of life in prior treatment experienced patients with chronic hepatitis C infection using patient reported outcomes data from this trial, presented at The International Liver Congress 2018.
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