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A Phase 1/2, Open-Label, Randomized Parallel Arm, Intra-patient Dose Titration Study to Evaluate Safety, PK and Preliminary Efficacy of CNSA-001 in Adult/Adolescent Primary Tetrahydrobiopterin Deficient Patients With Hyperphenylalaninemia

Trial Profile

A Phase 1/2, Open-Label, Randomized Parallel Arm, Intra-patient Dose Titration Study to Evaluate Safety, PK and Preliminary Efficacy of CNSA-001 in Adult/Adolescent Primary Tetrahydrobiopterin Deficient Patients With Hyperphenylalaninemia

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Oct 2018

At a glance

  • Drugs CNSA-001 (Primary)
  • Indications Hyperphenylalaninaemia
  • Focus Adverse reactions; Proof of concept
  • Sponsors Censa Pharmaceuticals
  • Most Recent Events

    • 15 Oct 2018 Planned End Date changed from 1 Oct 2018 to 1 Mar 2019.
    • 15 Oct 2018 Planned primary completion date changed from 1 Oct 2018 to 1 Mar 2019.
    • 19 Jul 2018 Planned End Date changed from 1 Sep 2018 to 1 Oct 2018.
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