Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
Study NCT ID:
NCT00214734
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2005-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ADVATE Post Authorization Safety Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Germany', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2007-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2005-09-15', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Hemophilia A']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b5fc94db2bf003ab46231', 'label': 'To obtain more information on the study, click here/on this link.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)\n* Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)\n* Subject has been prescribed ADVATE by their treating physician\n* Subject may be of any age\n* Subject or parent/legally authorized representative has provided written informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00214734', 'briefTitle': 'ADVATE Post Authorization Safety Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study', 'orgStudyIdInfo': {'id': 'ADVATE PASS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rAHF-PFM', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'PHOENIX CHILDRENS Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Childrens Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'LONG BEACH MEMORIAL MED Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93638', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Valley Children'S Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': "Children'S Hospital of S.W. Florida", 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'BIODORON', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children'S Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "NEMOURS CHILDREN'S CLINIC- Orlando", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "Tampa Children'S Hospital At St. Joes", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Southern Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Presbyterian - St. Lukes Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Children´s Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hemophilia & Thrombosis Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ Hosp & Clinic', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Med. Ctr Htc', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'PHS DEVOS CHILDRENS Hospital', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'MUNSON MED Center', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children'S Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Ted R. Montoya Hemophilia Treatment Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Phs Childrens Hosp Med Ctr Akron', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Youngstown HTC', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Childrens Hosp of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19134-1095', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'St. Christopher´s Hospital for Children, Section of Hematology/Oncology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37920-6999', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Phs-So Tx Hemo Ctr-San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': "Children'S Hospital of the King'S Daughters", 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baxter BioScience', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}