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A Phase 1/2, Open-Label, Randomized Parallel Arm, Intra-patient Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of CNSA-001(Sepiapterin) in Primary Tetrahydrobiopterin Deficient Patients With Hyperphenylalaninemia

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A Phase 1/2, Open-Label, Randomized Parallel Arm, Intra-patient Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of CNSA-001(Sepiapterin) in Primary Tetrahydrobiopterin Deficient Patients With Hyperphenylalaninemia

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 20 Nov 2023

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At a glance

  • Drugs Sepiapterin (Primary)
  • Indications Hyperphenylalaninaemia
  • Focus Adverse reactions; Proof of concept
  • Sponsors Censa Pharmaceuticals; PTC Therapeutics

    • Most Recent Events

    • 04 Jan 2021 Status changed from active, no longer recruiting to completed.
    • 16 Sep 2020 Status changed from recruiting to active, no longer recruiting.
    • 06 Jul 2020 Planned End Date changed from 31 May 2020 to 30 Nov 2020.

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