Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086658
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2004-07-07
Brief Title:
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes HES
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study 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
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 damages including skin heart lung nervous system and digestive system etc and with exclusion of known secondary causes of hypereosinophilia
HES has a high morbiditymortality 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
HES has a high morbiditymortality 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
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 with Hypereosinophilic Syndromes HES and to evaluate the Efficacy and Safety of Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None