Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT06158334
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2023-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Surgical Practices in Patients With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], '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': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-06-19', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative haemostatic efficacy described in real life with ELOCTA® and ALPROLIX® in haemophilia A and B patients. Haemostatic efficacy is defined by excellent, good, fair, poor.', 'timeFrame': '15 days post-surgery', 'description': 'changes in hemostatic efficacy between surgery and 15 days post-surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surgery', 'Haemophilia A', 'Haemophilia B', 'Elocta®', 'Alprolix®'], 'conditions': ['Hemophilia A', 'Hemophilia B']}, 'descriptionModule': {'briefSummary': 'Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with haemophilia is commonly managed with replacement therapy.\n\nIn phase 3 studies of Elocta® (extended half-life recombinant factor VIII-Fc) and Alprolix® (extended half-life recombinant factor IX-Fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating FVIII and FIX levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. In 2019, the National Protocol for Diagnosis and Care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor VIII/IX or a continuous infusion of FVIII/IX.\n\nMany countries, including France, have adopted these rFVIII/IXFc therapeuitic products and recommended their use in the surgical management of patients. However, the use of these two products in real life during surgery in haemophilic A and B patients has not been described in detail. It seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (minor and adults) with Haemophilia A or B for whom minor and major surgeries is performed with Elocta® or Alprolix®.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with Haemophilia A or B\n* surgery performed with Elocta® or Alprolix®\n* Information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors\n\nExclusion Criteria:\n\n* Any blood coagulation disorder other than Haemophilia A or B\n* Patient with factor VIII or IX inhibitor\n* Severe liver disease (serum ALAT/ASAT levels\\> 5 x ULN)\n* Severe renal disease (serum creatinine \\> 2x ULN)\n* Known hypersensitivity to the substances or its excipients\n* patient participating in another clinical trial or having participated in another clinical trial within the previous 30 days (non-interventional studies are not a criterion for non-inclusion)'}, 'identificationModule': {'nctId': 'NCT06158334', 'acronym': 'CHALE', 'briefTitle': 'Study of Surgical Practices in Patients With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Study of Surgical Practices in Patient With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)', 'orgStudyIdInfo': {'id': '868'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Minor and major surgeries of patients with haemophilia A treated with Elocta®', 'description': 'Description of all surgical data (minor and major) on Elocta® (all dosage and treatment regimens)', 'interventionNames': ['Drug: Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures']}, {'label': 'Minor and major surgeries of patients with haemophilia B treated with Alprolix®', 'description': 'Description of all surgical data (minor and major) on Alprolix® (all dosage and treatment regimens)', 'interventionNames': ['Drug: Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures']}], 'interventions': [{'name': 'Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures', 'type': 'DRUG', 'description': 'All surgical data will be collected: surgery, biology, administration of Elocta®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding', 'armGroupLabels': ['Minor and major surgeries of patients with haemophilia A treated with Elocta®']}, {'name': 'Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures', 'type': 'DRUG', 'description': 'All surgical data will be collected: surgery, biology, administration of Alprolix®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding…', 'armGroupLabels': ['Minor and major surgeries of patients with haemophilia B treated with Alprolix®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne LIENHART, MD', 'role': 'CONTACT'}], 'facility': 'Centre de Référence en Hémophilie, hôpityal Louis Pradel, GHE- Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Anne LIEHNART, MD', 'role': 'CONTACT', 'email': 'anne.lienhart@chu-lyon.fr', 'phone': '+33 4 72 11 88 10'}, {'name': 'Emilie PROME COMBEL, RCA', 'role': 'CONTACT', 'email': 'emilie.prome@chu-lyon.fr', 'phone': '+33 4 72 11 66 99'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}