Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-21 @ 9:06 PM
Study NCT ID:
NCT02781766
Status:
UNKNOWN
Last Update Posted:
2019-07-10
First Post:
2016-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TGA (Thrombin Generation Assay) and Prophylaxis in Haemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-09-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2016-05-23', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between the trough TGA (ETP) results of severe haemophilia patients who are on prophylaxis and the clinical efficacy of the ongoing prophylaxis regimen will be studied', 'timeFrame': 'The clinical efficacy of prophylaxis will be evaluated on the basis of the number of spontaneous joint bleeds the number of other relevant spontaneous bleeds and the consumption of clotting factor concentrate in the last 6 months prior to TGA.'}], 'secondaryOutcomes': [{'measure': 'The correlation between the trough FVIII:C results of severe haemophilia patients who are on prophylaxis and the clinical efficacy of the ongoing prophylaxis regimen will be studied', 'timeFrame': 'The clinical efficacy of prophylaxis will be evaluated on the basis of the number of spontaneous joint bleeds the number of other relevant spontaneous bleeds and the consumption of clotting factor concentrate in the last 6 months prior to FVIII.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Haemophilia A', 'prophylaxis', 'thrombin generation assay', 'factor VIII', 'prophylactic therapy'], 'conditions': ['Haemophilia A']}, 'descriptionModule': {'briefSummary': 'Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds and other serious bleeding events, prophylactic factor replacement therapy is used. Because of the high cost and limited availability of clotting factor concentrates, dosing is a crucial issue for prophylaxis therapy. Several studies reported a better correlation between clinical bleeding tendency of patients with haemophilia and thrombin generation assay results compared to FVIII/FIX levels. However there is no specific data showing that thrombin generation may be a better indicator of the clinical efficacy of prophylaxis compared to the conventional FVIII measurement.\n\nThe main objective of this open, multicentre, prospective study is to compare trough thrombin generation capacity and FVIII levels in severe haemophilia patients and compare these two laboratory results with:\n\n* the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in the last 6 months\n* the number of additional FVIII units used in the last 6 months\n\nThis project requires no change in term of type of treatment : During the study, each patient will be treated by his usual clotting factor at the usual regimen (frequency and dosage).\n\nThe clinical outcome with the usual prophylaxis regimen will be correlated to TGA results'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Severe haemophilia A (FVIII \\< 1 IU/dl)\n* Currently on prophylactic therapy\n* The same prophylaxis regimen in the last six months\n* Age: 2 (with a body weight ≥12.5 kg ) - 45 years\n* Adequate venous access\n* Haemophilia patient's diary or equivalent regularly completed\n* Ability of patient or family (for minors) to give informed consent\n* Subject with health insurance\n\nExclusion Criteria:\n\n* Age \\<2 and \\>45 years\n* Haemophilia A with documented inhibitor in the last 12 months\n* Clinically symptomatic liver disease (historical evidence documented in patient's medical file)\n* Platelet count \\< 100x109/l\n* Poor venous access\n* Presence of a documented target joint\n* Subject under legal protection measure."}, 'identificationModule': {'nctId': 'NCT02781766', 'acronym': 'HOPE', 'briefTitle': 'TGA (Thrombin Generation Assay) and Prophylaxis in Haemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Thrombin Generation Capacity of Patients With Severe Haemophilia Receiving Prophylaxis', 'orgStudyIdInfo': {'id': '2012-765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'One arm: patients with severe haemophilia A on prophylaxis', 'description': "Patients with severe haemophilia A (FVIII \\< 1 IU/dl), currently on prophylactic therapy , having the same prophylaxis regimen in the last six months, aged between 2 (with a body weight ≥12.5 kg ) and 45 years , with adequate venous access, having patient's diary or equivalent regularly completed and able to give informed consent", 'interventionNames': ['Other: Thrombin generation measurement.']}], 'interventions': [{'name': 'Thrombin generation measurement.', 'type': 'OTHER', 'armGroupLabels': ['One arm: patients with severe haemophilia A on prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabine CASTET', 'role': 'CONTACT', 'email': 'sabine-marie.castet@chu-bordeaux.fr', 'phone': '05 56 79 48 79', 'phoneExt': '+33'}, {'name': 'Sabine CASTET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yesim DARGAUD, Pr', 'role': 'CONTACT', 'email': 'ydargaud@univ-lyon1.fr', 'phone': '(0)4.72.11.88.10', 'phoneExt': '+33'}], 'facility': "Unité d'Hémostase Clinique Centre Régional de Traitement des Hémophiles Centre de Référence de Maladies Hémorragiques Hôpital Cardiologique Louis Pradel", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '73011', 'city': 'Chambéry', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valérie GAY', 'role': 'CONTACT', 'email': 'valerie.gay@ch-metropole-savoie.fr', 'phone': '04 72 96 56 65', 'phoneExt': '+33'}, {'name': 'Valérie GAY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Metropole Savoie site de Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '21079', 'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabienne GENRE VOLOT', 'role': 'CONTACT', 'email': 'fabienne.volot@chu-dijon.fr', 'phone': '03 80 29 32 57', 'phoneExt': '+33'}, {'name': 'Fabienne GENRE VOLOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Dijon Bourgogne Hôpital François Mitterrand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '13385', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hervé CHAMBOST', 'role': 'CONTACT', 'email': 'herve.chambost@ap-hm.fr', 'phone': '04 91 38 67 78', 'phoneExt': '+33'}, {'name': 'Hervé CHAMBOST', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc TROSSAERT', 'role': 'CONTACT', 'email': 'marc.trossaert@chu-nantes.fr', 'phone': '04 20 08 74 68', 'phoneExt': '+33'}, {'name': 'Marc TROSSAERT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '42055', 'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brigitte TARDY', 'role': 'CONTACT', 'email': 'brigitte.tardy@chu-st-etienne.fr', 'phone': '04 77 12 78 63', 'phoneExt': '+33'}, {'name': 'Claire BERGER', 'role': 'CONTACT', 'email': 'claire.berger@chu-st-etienne.fr', 'phone': '04 77 82 88 08', 'phoneExt': '+33'}, {'name': 'Brigitte TARDY', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Claire BERGER', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Saint Etienne - Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Yesim DARGAUD, Pr', 'role': 'CONTACT', 'email': 'ydargaud@univ-lyon1.fr', 'phone': '(0)4.72.11.88.10', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}