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Multicenter, Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 1.0 mg/kg Macimorelin Acetate as Growth Hormone Stimulation Test (GHST) in Pediatric Patients With Suspected Growth Hormone Deficiency (GHD)

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Trial Profile

Multicenter, Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 1.0 mg/kg Macimorelin Acetate as Growth Hormone Stimulation Test (GHST) in Pediatric Patients With Suspected Growth Hormone Deficiency (GHD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2024

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At a glance

  • Drugs Macimorelin (Primary) ; Arginine; Clonidine
  • Indications Somatotropin deficiency
  • Focus Diagnostic use; Registrational
  • Acronyms DETECT
  • Sponsors AEterna Zentaris Inc

Most Recent Events

  • 12 Nov 2024 According to COSCIENS Biopharma Media Release, detailed analysis of results of safety and efficacy data are in progress following which a decision will be made whether future investment in macimorelin for the diagnosis of CGHD is warranted.
  • 27 Aug 2024 According to COSCIENS Biopharma Media Release, Full trial result reporting is expected to occur later this year.
  • 27 Aug 2024 According to COSCIENS Biopharma Media Release, Primary endpoint (Area under the Receiver Operator Characteristic curve (ROC AUC) based on GH concentration during GHST following macimorelin administration)has not been met.

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