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.
Ages: 12 years and younger
Start Date: 11/22/2008
End Date: 01/31/2020
Last Updated: 02/22/2018
Study HIC#: 0810004339