Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
NCT ID: NCT00086658
Last Updated: 2020-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
86 participants
INTERVENTIONAL
2004-03-23
2006-05-01
Brief Summary
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HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.
Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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mepolizumab
Eligibility Criteria
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Inclusion Criteria
* Eosinophil count greater than 1500 cells for 6 months
* Signs and symptoms of organ system involvement
* No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.
* Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.
* Not pregnant or nursing.
Exclusion Criteria
* Wegener's Granulomatosis
* Lymphoma, hematological malignancy, advanced and metastatic solid tumors
* Chemotherapy, radiotherapy or interleukin 2 treatment.
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Bethesda, Maryland, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Rochester, Minnesota, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Madison, Wisconsin, United States
GSK Investigational Site
St Leonards, New South Wales, Australia
GSK Investigational Site
South Brisbane, Queensland, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
West Perth, Western Australia, Australia
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Hamilton, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Lille, , France
GSK Investigational Site
Suresnes, , France
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany
GSK Investigational Site
Bologna, Emilia-Romagna, Italy
GSK Investigational Site
Bern, , Switzerland
Countries
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References
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Roufosse F, de Lavareille A, Schandene L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049.
Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16.
Other Identifiers
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100185
Identifier Type: -
Identifier Source: org_study_id
NCT00081445
Identifier Type: -
Identifier Source: nct_alias
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