Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 10:09 PM
Study NCT ID:
NCT00718692
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2008-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558236', 'term': 'rozrolimupab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'dispFirstSubmitDate': '2015-11-25', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2008-07-18', 'dispFirstSubmitQcDate': '2016-04-11', 'studyFirstSubmitQcDate': '2008-07-18', 'dispFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)', 'timeFrame': '6 weeks post dosing'}], 'secondaryOutcomes': [{'measure': 'Measurements of platelet counts', 'timeFrame': 'From day 1 through week 6'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Idiopathic', 'ITP'], 'conditions': ['Immune Thrombocytopenic Purpura']}, 'referencesModule': {'references': [{'pmid': '22915649', 'type': 'RESULT', 'citation': 'Robak T, Windyga J, Trelinski J, von Depka Prondzinski M, Giagounidis A, Doyen C, Janssens A, Alvarez-Roman MT, Jarque I, Loscertales J, Rus GP, Hellmann A, Jedrzejczak WW, Kuliczkowski K, Golubovic LM, Celeketic D, Cucuianu A, Gheorghita E, Lazaroiu M, Shpilberg O, Attias D, Karyagina E, Svetlana K, Vilchevska K, Cooper N, Talks K, Prabhu M, Sripada P, Bharadwaj TP, Naested H, Skartved NJ, Frandsen TP, Flensburg MF, Andersen PS, Petersen J. Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia. Blood. 2012 Nov 1;120(18):3670-6. doi: 10.1182/blood-2012-06-438804. Epub 2012 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed presence of thrombocytopenia with platelet count \\< 30,000/mm3 at the pre-dose visit.\n* History of isolated ITP\n* RhD-positive serology.\n* Previous treatment and response to first line therapy for ITP\n\nExclusion Criteria:\n\n* Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.\n* Suspected infection with HIV, Hepatitis C, H. pylori.\n* Clinical splenomegaly\n* History of abnormal bone marrow examination.\n* Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.\n* Underlying haemolytic condition\n* History of splenectomy.\n* Subject is pregnant, breast feeding or intends to become pregnant.'}, 'identificationModule': {'nctId': 'NCT00718692', 'briefTitle': 'Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Symphogen A/S'}, 'officialTitle': 'A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.', 'orgStudyIdInfo': {'id': 'Sym001-03'}, 'secondaryIdInfos': [{'id': '2007-006081-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients treated with Sym001', 'interventionNames': ['Drug: Sym001']}], 'interventions': [{'name': 'Sym001', 'type': 'DRUG', 'description': 'Each cohort will receive one single dose of Sym001 according the assigned dose level.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Univ Nebraska Med Ctr. UNMC, 1005', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania, Site 1002', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': '2085 Henry Tecklenburg Drive, 1001', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'Research Site 3203', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Site 3202', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Research Site 3201', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site 4906, 4907', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Research Site 4902', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Duisburg', 'country': 'Germany', 'facility': 'Research Site 4903', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Research Site 4905', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Reseach Site 4908', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Research Site 4901', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Regensburg', 'country': 'Germany', 'facility': 'Research Site 4904', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '560034', 'city': 'Bangalore', 'country': 'India', 'facility': "St. John's Medical College Hospital, 9106", 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560054', 'city': 'Bangalore', 'country': 'India', 'facility': 'MS Ramaiah Memorial Hospital, 9108', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560099', 'city': 'Bangalore', 'country': 'India', 'facility': 'Narayana Hrudayalaya Hospitals, 9105', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '576104', 'city': 'Bangalore', 'country': 'India', 'facility': 'Columbia Asia Referral Hospital-Yeshwanthpur, 9101', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '600010', 'city': 'Chennai', 'country': 'India', 'facility': 'Aysha Hospital Pvt. 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