Last updated: 10/01/2020 13:30:16
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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 HES
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
86
Primary completion date:
2006-01-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
F Roufosse, A de Lavareille, L Schandené, E Cogan, L Wagner, M Raffeld, A Klion, G Gleich, M Goldman. Mepolizumab as a Corticosteroid-sparing Agent in Lymphocytic Variant Hypereosinophilic Syndrome. J Allergy Clin Immunol. 2010;126:828-35.
Schwartz LB, Sheikh J, Singh A. Use of Mepolizumab as Corticosteroid-Sparing Therapy in Patients with Hypereosinophilic Syndrome: Report of Three Cases. Curr Med Res Opin. 2010;26(8):1933-46.
- Inclusion criteria:
- Documented history of Hypereosinophilic Syndrome (HES)
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20892
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Showing 1 - 6 of 29 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2006-01-03
Actual study completion date
2006-01-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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