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A phase I, open-label single-dose study analyzing pharmacokinetics of Remdesivir and its metabolites in participants with mild to severe hepatic impairment

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Trial Profile

A phase I, open-label single-dose study analyzing pharmacokinetics of Remdesivir and its metabolites in participants with mild to severe hepatic impairment

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Sep 2023

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At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Gilead Sciences

Most Recent Events

  • 19 Sep 2023 According to a Gilead Sciences media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury (remdesivir) to treat people with COVID-19 with mild to severe hepatic impairment. The positive opinion was based on results from this study. Based upon these results, the revised recommendation requires no dose adjustment or liver function testing before or during treatment.
  • 24 Aug 2023 According to a Gilead Sciences media release, the approval follows recent FDA and European Commission decisions to extend approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis.
  • 24 Aug 2023 According to a Gilead Sciences media release, based on results from this study, U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment.

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