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

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2017

At a glance

  • Drugs Sapropterin (Primary)
  • Indications Phenylketonuria
  • Focus Therapeutic Use
  • Sponsors BioMarin Pharmaceutical
  • Most Recent Events

    • 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.
    • 28 Dec 2015 New trial record
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