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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00244686 |
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 treat subjects with HES who have significant clinical disease due to HES, are unresponsive to medication used to treat HES and those who have demonstrated clinical benefit with previous anti IL-5 treatment. The overall objective of this compassionate use supply program is to assess the safety and effectiveness of treatment with Mepolizumab in subjects with severe HES and subjects who previously benefited from anti-IL5 therapy.
Condition | Intervention | Phase |
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Hypereosinophilic Syndrome |
Drug: mepolizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome |
Estimated Enrollment: | 50 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Meets the diagnostic criteria for Hyper Eosinophilic Syndrome as defined by:
Subjects with eosinophilia of >1500/ul for less than 6 months who meet the other criteria for HES accompanied by clear evidence of eosinophil tissue infiltration and with exclusion for secondary causes of eosinophilia as above.
3.Has ongoing HES, as judged by documented treatment failure defined as life-threatening or severely disabling signs of HES in association with documented eosinophil count ≥ 1000µl on > 1 occasion with documented failure to respond to at least one agent in each category of available therapies; a) systemic corticosteroid, b) cytotoxic agent, c) alpha interferon, and d) Imatinib for FIP1L1-PDGRF-alpha fusion gene positive cases, at the appropriate duration and dose.
OR, MEETS THE FOLLOWING CRITERIA
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MHE104317 |
Study First Received: | October 25, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00244686 |
Health Authority: | United States: Food and Drug Administration |
Compassionate Use Mepolizumab Hypereosinophilic Syndrome HES Mepo |
Idiopathic hypereosinophilic syndrome Hematologic Diseases Hypereosinophilic Syndrome |
Leukocyte Disorders Hypereosinophilic syndrome Eosinophilia |
Pathologic Processes Disease Syndrome |