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A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

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Trial Profile

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Nov 2020

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At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 19 Mar 2020 According to a Gilead Sciences media release, the recommended dosage of Epclusa in children ages 6 years and older is based on weight and liver function.This expanded approval of Epclusa is based on data from this Phase 2, open-label clinical trial (Study 1143).
    • 19 Mar 2020 According to a Gilead Sciences media release, the U.S. FDA has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity.
    • 03 Mar 2020 Status changed from active, no longer recruiting to completed.

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