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A Phase 3, Open-Label, Randomized, Multi-Center Study to Assess the Safety & Tolerability of an Induction, Titration, and Maintenance Dose Regimen of BMN 165 Self Administered by Adults With PKU Not Previously Treated With BMN 165

Trial Profile

A Phase 3, Open-Label, Randomized, Multi-Center Study to Assess the Safety & Tolerability of an Induction, Titration, and Maintenance Dose Regimen of BMN 165 Self Administered by Adults With PKU Not Previously Treated With BMN 165

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2019

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At a glance

  • Drugs Pegvaliase (Primary)
  • Indications Phenylketonuria
  • Focus Adverse reactions
  • Acronyms PRISM-1; Prism301
  • Sponsors BioMarin Pharmaceutical
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 18 Jul 2018 Results from (NCT00634660, NCT01560286, NCT00925054, NCT01212744, NCT00924703, NCT01819727 and NCT01889862) published in the BioDrugs
    • 21 Mar 2016 According to a BioMarin media release, the company intends to submit a marketing application by the end of 2016 subject to further discussions with the FDA. The results from this study will be presented at the Society of Inherited Metabolic Disorders in April of 2016.
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