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A Phase 3b Open-Label Study to Evaluate the Effect of Kuvan on Neurocognitive Function, Maintenance of Blood Phenylalanine Concentrations, Safety, and Population Pharmacokinetics in Young Children With Phenylketonuria

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Trial Profile

A Phase 3b Open-Label Study to Evaluate the Effect of Kuvan on Neurocognitive Function, Maintenance of Blood Phenylalanine Concentrations, Safety, and Population Pharmacokinetics in Young Children With Phenylketonuria

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Sapropterin (Primary)
  • Indications Phenylketonuria
  • Focus Registrational; Therapeutic Use
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 22 Jan 2019 Status changed from active, no longer recruiting to completed.
  • 10 Jan 2017 Planned End Date changed from 1 Dec 2018 to 1 Jan 2020.
  • 10 Jan 2017 Planned primary completion date changed from 1 Dec 2018 to 1 Aug 2019.

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