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A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naive Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV

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Trial Profile

A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naive Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Elbasvir/grazoprevir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms C-EDGE CO-INFXN; C-EDGE COINFECTION
  • 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 analysis assessing the relationship between treatment of coinfected HCV/HIV patients with Elbasvir and Grazoprevir and time-dependent mean change in health related quality of life, presented at The International Liver Congress 2018.

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