Status:
COMPLETED
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypereosinophilia
Hypereosinophilic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously in Subjects wi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Documented history of Hypereosinophilic Syndrome (HES)
- 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:
- Churg-Strauss Syndrome
- Wegener's Granulomatosis
- Lymphoma, hematological malignancy, advanced and metastatic solid tumors
- Chemotherapy, radiotherapy or interleukin 2 treatment.
Exclusion
Key Trial Info
Start Date :
March 23 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00086658
Start Date
March 23 2004
End Date
May 1 2006
Last Update
May 5 2020
Active Locations (29)
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1
GSK Investigational Site
San Diego, California, United States, 92103
2
GSK Investigational Site
Denver, Colorado, United States, 80206
3
GSK Investigational Site
Bethesda, Maryland, United States, 20892
4
GSK Investigational Site
Boston, Massachusetts, United States, 02215