Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 6:13 PM
Study NCT ID:
NCT00122304
Status:
COMPLETED
Last Update Posted:
2007-02-21
First Post:
2005-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006457', 'term': 'Hemoglobinuria, Paroxysmal'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C481642', 'term': 'eculizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2006-11'}, 'lastUpdateSubmitDate': '2007-02-20', 'studyFirstSubmitDate': '2005-07-19', 'studyFirstSubmitQcDate': '2005-07-19', 'lastUpdatePostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptable safety (adverse events [AEs], labs, electrocardiograms [ECGs], vital signs)'}, {'measure': 'Primary surrogate of efficacy endpoint is hemolysis measured by LDH area under the curve.'}], 'secondaryOutcomes': [{'measure': 'Hemolysis measured by the change of LDH from baseline;'}, {'measure': 'Quality of Life'}]}, 'conditionsModule': {'conditions': ['Hemoglobinuria, Paroxysmal']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PNH \\> 6 months\n* Type III PNH red blood cell (RBC) clone by flow cytometry \\>10%\n* At least one transfusion in the past 2 years but no more than 3 transfusions in the past 12 months; or personal beliefs that preclude the use of transfusion with severe hemolytic PNH\n* Lactate dehydrogenase (LDH) \\>1.5 x upper limit of normal\n* Must avoid conception\n* Willing and able to give written informed consent\n\nExclusion Criteria:\n\n* Platelet count of \\<30,000/mm3\n* Absolute neutrophil count \\<500/ul\n* Active bacterial infection\n* Hereditary complement deficiency\n* History of bone marrow transplantation\n* Participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days\n* Pregnant, breast-feeding, or intending to conceive\n* History of meningococcal disease'}, 'identificationModule': {'nctId': 'NCT00122304', 'briefTitle': 'Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab', 'nctIdAliases': ['NCT00133120'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study', 'orgStudyIdInfo': {'id': 'SHEPHERD'}, 'secondaryIdInfos': [{'id': 'C04-002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'eculizumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center, Division of Hematology', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital, Cancer Clinical Research Office', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida, Dept. of Clinical Research', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Pavilion', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Heart, Lung, and Blood Institute, National Institutes of Health', 'geoPoint': {'lat': 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45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, Hematology-BMT Department', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '2065', 'city': 'Saint Leonard', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital, Haematology Department'}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital, Oncology Haematology Radiation Department', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5011', 'city': 'Woodville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital, 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'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '10 75475', 'city': 'Paris', 'state': 'Cedex', 'country': 'France', 'facility': "Hopital Saint-Louis, Centre d'investigation Clinique", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D-45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitatsklinikum Essen, Zentrum fur Innere Medizin', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Abt. 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