Compassionate Use of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES)

What is the purpose of this trial?

It is thought that from the efficacy and safety information to date, it is possible that subjects with severe or life-threatening HES, and limited treatment options (unresponsive or intolerant to available HES medication), may benefit from mepolizumab treatment. Such subjects will not be able to access mepolizumab through the aforementioned clinical trials due to the severity of their disease. Waiting for regulatory approval would delay access. It is this population of subjects in whom there is a clear unmet medical need, and in whom the benefit to risk ratio is thought appropriate, who will be considered for compassionate use of mepolizumab. This view is echoed by the physicians caring for subjects with HES.

GSK will sponsor this compassionate use trial of mepolizumab to provided access to treatment in subjects determined by their treating physicians to have life threatening HES and in who there is documented failure to at least 3 standard therapies used to treat HES.


Participation Guidelines

Ages: 12 years and younger

Gender: Both


GlaxoSmithKline, LLC

Start Date: 11/22/2008

End Date: 01/31/2020

Last Updated: 02/22/2018

Study HIC#: 0810004339

Get Involved

For more information about this study, contact:
Carole T Holm
+1 203-737-4263
carole.holm@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Geoffrey Lowell Chupp

Principal Investigator

Sub-Investigators