Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT00086658
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2004-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}], 'ancestors': [{'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C434107', 'term': 'mepolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03-23', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2006-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-01', 'studyFirstSubmitDate': '2004-07-07', 'studyFirstSubmitQcDate': '2004-07-08', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks'}], 'secondaryOutcomes': [{'measure': '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.'}]}, 'conditionsModule': {'keywords': ['Hypereosinophilic Syndrome Hypereosinophilia', 'mepolizumab', 'anti IL-5'], 'conditions': ['Hypereosinophilia', 'Hypereosinophilic Syndrome']}, 'referencesModule': {'references': [{'pmid': '20810155', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '18344568', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHES 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.\n\nMepolizumab 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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Documented history of Hypereosinophilic Syndrome (HES)\n* Eosinophil count greater than 1500 cells for 6 months\n* Signs and symptoms of organ system involvement\n* No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.\n* Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.\n* Not pregnant or nursing.\n\nExclusion criteria:\n\n* Churg-Strauss Syndrome\n* Wegener's Granulomatosis\n* Lymphoma, hematological malignancy, advanced and metastatic solid tumors\n* Chemotherapy, radiotherapy or interleukin 2 treatment."}, 'identificationModule': {'nctId': 'NCT00086658', 'briefTitle': 'Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)', 'nctIdAliases': ['NCT00081445'], 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '100185'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mepolizumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37203-1424', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298-0568', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6005', 'city': 'West Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -31.94896, 'lon': 115.84199}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3C 0N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5V 2T3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '80802', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '24576', 'city': 'Bad Bramstedt', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}