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A phase 2, open-label clinical trial of Epclusa for the treatment of chronic hepatitis C virus (HCV) in children

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Trial Profile

A phase 2, open-label clinical trial of Epclusa for the treatment of chronic hepatitis C virus (HCV) in children

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Jun 2021

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At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 17 Jun 2021 New trial record
    • 10 Jun 2021 According to a Gilead Sciences media release, The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children ages 3 years and older is based on weight.
    • 10 Jun 2021 According to a Gilead Sciences media release, based on the data from this trial, the U.S. FDA has approved an expansion of the pediatric indication of Epclusa for the treatment of chronic hepatitis C virus to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity.

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