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A multicentre, open-label, extension study, evaluating the safety and tolerability and the efficacy of ADV7103 at long term in distal renal tubular acidosis patients. (Multicentrické, otvorené, predĺžené klinické skúšanie na hodnotenie bezpečnosti, znášanlivosti a účinnosti produktu ADV7103 z dlhodobého hľadiska u pacientov s distálnou renálnou tubulárnou acidózou.)

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A multicentre, open-label, extension study, evaluating the safety and tolerability and the efficacy of ADV7103 at long term in distal renal tubular acidosis patients. (Multicentrické, otvorené, predĺžené klinické skúšanie na hodnotenie bezpečnosti, znášanlivosti a účinnosti produktu ADV7103 z dlhodobého hľadiska u pacientov s distálnou renálnou tubulárnou acidózou.)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jan 2022

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At a glance

  • Drugs Potassium bicarbonate/potassium citrate (Primary)
  • Indications Renal tubular acidosis
  • Focus Adverse reactions; Registrational
  • Sponsors Advicenne

    • Most Recent Events

    • 20 May 2021 Results assessing the adherence to ADV7103 in a cohort of paediatric and adult patients after 24 months of treatment, presented at the 26th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 17 May 2021 According to an Advicenne media release, the the European Medicines Agency (EMA) has approved the Marketing Authorization Application (MAA) for ADV7103 as a treatment for distal renal tubular acidosis (dRTA).
    • 07 Jun 2019 Status changed from recruiting to completed.

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