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A Phase 4 Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-Old Children with Phenylketonuria Treated with Sapropterin Dihydrochloride (Kuvan) for 7 Years

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Trial Profile

A Phase 4 Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-Old Children with Phenylketonuria Treated with Sapropterin Dihydrochloride (Kuvan) for 7 Years

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 20 Oct 2023

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At a glance

  • Drugs Sapropterin (Primary)
  • Indications Phenylketonuria
  • Focus Therapeutic Use
  • Acronyms KOGNITO
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 21 Apr 2023 Status changed from active, no longer recruiting to completed.
  • 19 Dec 2022 This trial has been completed in Germany(Global End Date: 26 Jan 2016), according to European Clinical Trials Database record.
  • 27 Jul 2020 This trial is completed in UK (Global End Date: 26 Jan 2016), according to European Clinical Trials Database record.

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