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NCT00086658 · ClinicalTrials.gov registry record · Phase 3
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
NCT00086658 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 86 participants.
The verdict
NCT00086658, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
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.
Interventions
- DRUG mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2004-03-23 |
| Est. Completion | 2006-05-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00086658
The ClinicalTrials.gov registry entry for NCT00086658 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which mepolizumab is the first listed.
NCT00086658 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00086658 about?
NCT00086658 is a clinical study titled "Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)". 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 ...
What is the current status of trial NCT00086658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2004-03-23. Estimated completion is 2006-05-01.
What interventions are being tested in trial NCT00086658?
The interventions under investigation include: mepolizumab (DRUG).
Who is sponsoring clinical trial NCT00086658?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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