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An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis

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Trial Profile

An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Jan 2022

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At a glance

  • Drugs Etelcalcetide (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Adverse reactions
  • Sponsors Amgen

    • Most Recent Events

    • 16 Nov 2018 Status changed from active, no longer recruiting to completed.
    • 29 Oct 2018 Planned End Date changed from 30 Nov 2018 to 2 Nov 2018.
    • 29 Oct 2018 Planned primary completion date changed from 30 Nov 2018 to 2 Nov 2018.

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