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: 20 Dec 2023
Price :
$35
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At a glance
- Drugs Eculizumab (Primary)
- Indications Myasthenia gravis
- Focus Registrational; Therapeutic Use
- Sponsors Alexion AstraZeneca Rare Disease
- 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.
- 27 Jul 2023 According to a AstraZeneca media release, John F. Brandsema is the primary investigator for this trial.