Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 9:26 AM
Study NCT ID:
NCT00927667
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2009-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-16', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum ankle MRI score', 'timeFrame': 'no timeframe (single visit, "snapshot" of the actual joint status)'}], 'secondaryOutcomes': [{'measure': 'Total MRI score of the maximum index joint', 'timeFrame': 'no timeframe (single visit, "snapshot" of the actual joint status)'}, {'measure': 'Number of bleeds in each index joint over previous 5 years', 'timeFrame': 'no timeframe (medical history status)'}, {'measure': 'Number of total joint bleeds and their locations over previous 5 years', 'timeFrame': 'no timeframe (medical history status)'}, {'measure': 'Physical joint score (Gilbert Score)', 'timeFrame': 'no timeframe (single visit, "snapshot" of the actual joint status)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemophilia A', 'Joint Status', 'Bleeds', 'Magnetic Resonce Imaging'], 'conditions': ['Hemophilia A']}, 'descriptionModule': {'briefSummary': 'The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 12 - 35 years\n* Severe hemophilia A ( \\< 1 % FVIII:C)\n* No history of Factor VIII inhibitory antibody\n* For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.\n* Complete documentation of joints bleeds and their locations prior to start of prophylaxis,\n* Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.\n* For the on-demand subjects \\> 12 bleeds/year in the last 5 years.\n* Written informed consent by subject and parent/legal representative, if \\< 18 years\n\nExclusion Criteria:\n\n* Individuals with other coagulopathies (e.g., von Willebrand disease)\n* HIV seropositive subjects\n* Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)\n* HCV seropositive individuals who underwent interferon therapy during the last 12 months\n* Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)\n* Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period\n* Joint replacement\n* For the on-demand treatment group, any period greater than 8 consecutive months having received \\>/= 50 IU per kg per week Factor VIII for the prevention of bleeding'}, 'identificationModule': {'nctId': 'NCT00927667', 'briefTitle': 'Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Diagnostic Interventional, Controlled, Cross-sectional Evaluation of Joint Status Using Magnetic Resonance Imaging in Subjects With Severe Hemophilia A Treated With Primary Prophylaxis, Secondary Prophylaxis, or On-demand Therapy', 'orgStudyIdInfo': {'id': '12948'}, 'secondaryIdInfos': [{'id': '2009-010147-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Procedure: No Drug']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Procedure: No Drug']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'interventionNames': ['Procedure: No Drug']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'interventionNames': ['Procedure: No Drug']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'interventionNames': ['Procedure: No Drug']}], 'interventions': [{'name': 'No Drug', 'type': 'PROCEDURE', 'description': 'Patients have received primary FVIII prophylaxis (started \\< 2 years of age)', 'armGroupLabels': ['Arm 1']}, {'name': 'No Drug', 'type': 'PROCEDURE', 'description': 'Patients have received secondary FVIII prophylaxis (started 2 - \\< 6 years of age)', 'armGroupLabels': ['Arm 2']}, {'name': 'No Drug', 'type': 'PROCEDURE', 'description': 'Patients have received secondary FVIII prophylaxis (started 6 - \\< 12 years of age)', 'armGroupLabels': ['Arm 3']}, {'name': 'No Drug', 'type': 'PROCEDURE', 'description': 'Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)', 'armGroupLabels': ['Arm 4']}, {'name': 'No Drug', 'type': 'PROCEDURE', 'description': 'Patients have received on-demand therapy', 'armGroupLabels': ['Arm 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69123', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '53105', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '48143', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '39112', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '35121', 'city': 'Padua', 'country': 'Italy', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'A Coruña', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'CT1 3NG', 'city': 'Canterbury', 'state': 'Kent', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Head Clinical Pharmacology', 'oldOrganization': 'Bayer Healthcare AG'}}}}