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A multicentre, randomised, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children

Trial Profile

A multicentre, randomised, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 13 Feb 2019

At a glance

  • Drugs Potassium bicarbonate/potassium citrate (Primary)
  • Indications Cystinuria
  • Focus Registrational; Therapeutic Use
  • Sponsors Advicenne
  • Most Recent Events

    • 08 Feb 2019 Planned End Date changed to 11 Dec 2020.
    • 08 Feb 2019 Status changed from planning to recruiting.
    • 15 May 2018 According to the Advicenne media release, this trial is expected to begin in 2018.
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