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An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia Gravis

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Trial Profile

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia Gravis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Dec 2024

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At a glance

  • Drugs Eculizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Sponsors Alexion AstraZeneca Rare Disease

Most Recent Events

  • 01 Jul 2024 Results(n=10 with mean age 14.8 years) evaluating the efficacy and safety of Eculizumab in adolescents published in the Pediatric Neurology.
  • 28 Nov 2023 Status changed from active, no longer recruiting to completed.
  • 24 Aug 2023 According to a AstraZeneca media release, Soliris (eculizumab) has been approved in Japan for expanded use to include the treatment of generalised myasthenia gravis (gMG) in paediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX), based on data from this trial.

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