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

Conditions

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

Age:
12 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
GlaxoSmithKline, LLC
Dates:
11/22/2008
Last Updated:
Study HIC#:
0810004339