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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00086658
Registration number
NCT00086658
Ethics application status
Date submitted
7/07/2004
Date registered
9/07/2004
Date last updated
5/05/2020
Titles & IDs
Public title
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
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Scientific 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
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Secondary ID [1]
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100185
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypereosinophilia
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Hypereosinophilic Syndrome
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks
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Secondary outcome [1]
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Assess the effect of mepo in lowering prednisone dose and blood eosinophil count, improving HES-associated skin manifestations, improving quality of life (QoL), safety and tolerability.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Churg-Strauss Syndrome
* Wegener's Granulomatosis
* Lymphoma, hematological malignancy, advanced and metastatic solid tumors
* Chemotherapy, radiotherapy or interleukin 2 treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/03/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2006
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Sample size
Target
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - St Leonards
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Recruitment hospital [2]
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GSK Investigational Site - South Brisbane
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GSK Investigational Site - Melbourne
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GSK Investigational Site - West Perth
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3050 - Melbourne
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Recruitment postcode(s) [4]
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6005 - West Perth
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Maryland
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Massachusetts
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Minnesota
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Ohio
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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France
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Lille
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France
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Suresnes
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Schleswig-Holstein
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Italy
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Emilia-Romagna
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Switzerland
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
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 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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Trial website
https://clinicaltrials.gov/study/NCT00086658
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Trial related presentations / publications
Roufosse F, de Lavareille A, Schandene L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049. Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16. Erratum In: N Engl J Med. 2008 Jun 5;358(23): 2530.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00086658
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