Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT04206033
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D007592', 'term': 'Joint Diseases'}], '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': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.', 'timeFrame': '1 year', 'description': 'Evaluation of the inflammatory profile of patients by protein assays'}], 'secondaryOutcomes': [{'measure': 'Find a correlation between the main objective and the measurement of bone density', 'timeFrame': '1 year', 'description': 'Evaluation of biochemical parameters involved in bone metabolism'}, {'measure': 'Find a correlation between the main objective and the measurement of bone density', 'timeFrame': '1 year', 'description': 'Non-invasive bone mineral density measurement'}, {'measure': 'Look for a correlation between the main objective and physical activity', 'timeFrame': '1 year', 'description': 'Assessment of physical activity by self-questionnaire'}, {'measure': 'Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.', 'timeFrame': '1 year', 'description': 'Evaluation of the inflammatory profile of patients by protein assays'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemophilia', 'Osteopenia', 'Arthropathy']}, 'descriptionModule': {'briefSummary': 'The investigators propose, as part of the study, to carry out for each patient:\n\n* An analysis of monocytic populations by flow cytometry (CD14, CD16, CD45, CD68, CD115, CCR2, CX3CR1, CD163 and CD206).\n* A population assessment of Myeloid-Derived Suppressor Cells (MDSC).\n* Assays of cytokines and chemokines involved in inflammation by multiplex analyzes: Il-1 (α and β), Il-4, Il-6, Il-10, Il-13, TNF- α, TGF- β, CRP , leptin, IFN- β.\n* Specialized dosages of proteins involved in bone metabolism. RANKL, osteoprotegerin, M-CSF, TRAPCP5.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'It will include adult male patients with hemophilia A or B, severe, moderate or minor.\n\nIn addition, the investigators will include patients with Hemophilia A with an inhibitor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patients followed at the hemophilia treatment reference center,\n* Presenting the diagnosis of severe, moderate or minor Hemophilia A / B,\n* Having a social security system,\n* Obtaining the oral non-objection collection from the patient after information.\n\nExclusion Criteria:\n\n* Minor patients, under guardianship or curatorship.\n* Causes of secondary osteoporosis:\n\n * Systemic corticosteroid therapy in progress (≥ 3 consecutive months, at a dosage ≥ 7.5 mg / d of prednisone equivalent).\n * other treatment or condition responsible for osteoporosis: prolonged or medicated hypogonadism, untreated active hyperthyroidism, hypercorticism, primary hyperparathyroidism.\n* Treatment with biphosphonates, biotherapies or hormone therapy in the treatment of prostate cancer.'}, 'identificationModule': {'nctId': 'NCT04206033', 'acronym': 'BOHEM', 'briefTitle': 'Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins', 'orgStudyIdInfo': {'id': 'RC19_0446'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'Observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}