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Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

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clinicaltrials.gov/study/NCT00086658
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT000866580
Health Conditions in Trial
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Hypereosinophilia
0
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Hypereosinophilic syndrome
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Trial Recruitment Size
860
Trial Sponsor
GlaxoSmithKline
GlaxoSmithKline
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Clinical Trial Start Date
March 23, 2004
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Primary Completion Date
May 1, 2006
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Study Completion Date
May 1, 2006
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Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 30
Official Name
A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES0
Last Updated
May 5, 2020
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Study summary

Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia. 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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