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A Phase 2, Randomized, Double Crossover, Open-Label, Active-Controlled Proof-of-Concept Study of CNSA-001 in Phenylketonuria Patients

Trial Profile

A Phase 2, Randomized, Double Crossover, Open-Label, Active-Controlled Proof-of-Concept Study of CNSA-001 in Phenylketonuria Patients

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Dec 2019

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At a glance

  • Drugs CNSA-001 (Primary) ; Sapropterin
  • Indications Phenylketonuria
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Censa Pharmaceuticals Australia
  • Most Recent Events

    • 03 Dec 2019 According to a Censa Pharmaceuticals media release, data will be presented at The American College of Medical Genetics and Genomics (ACMG) Meeting on March 18th, 2020.
    • 03 Dec 2019 According to a Censa Pharmaceuticals media release, primary endpoint (The primary objective of the study is to evaluate the Phenylalanine level as assessed by plasma and dried blood spot assay in adult PKU patients) has been met.
    • 22 Aug 2019 Status changed from recruiting to completed.
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