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A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy

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A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Glecaprevir/pibrentasvir (Primary) ; Ribavirin; Sofosbuvir
  • Indications Hepatitis C
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 20 May 2021 Results assessing prevalence and impact of baseline NS3 and NS5A resistance-associated substitutions (RASs) on the efficacy of G/P in prior GT1 sofosbuvir+NS5Ai failures and the persistence of treatment-emergent RASs, published in the Journal of Hepatology.
    • 17 Feb 2020 Status changed from active, no longer recruiting to completed.
    • 21 Jan 2020 Study design has been changed from crossover to parallel and treatment arm has been changed from 5 to 4. Trial focus also changed from TU to TU and AR.

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