Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06806618
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HAE Burden and Crisis Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054179', 'term': 'Angioedemas, Hereditary'}], 'ancestors': [{'id': 'D000799', 'term': 'Angioedema'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000081208', 'term': 'Hereditary Complement Deficiency Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the burden associated with the on-demand treatment of HAE attacks', 'timeFrame': 'The survey will focus on HAE attacks that have occurred within the last 12 months.', 'description': "The burden associated with the on-demand treatment of HAE attacks from the patient's and caregiver's perspective, will be described in terms of:\n\n* The frequency of HAE attacks.\n* The severity of HAE attacks.\n* Disease control.\n* Events that trigger the HAE attacks.\n* Frequency of injections for treating HAE attacks.\n* Delay in injections for treating HAE attacks.\n* Hospitalization for HAE attacks.\n* Impact on quality of life (during HAE attacks).\n* Impact on quality of life (between HAE attacks).\n* Social impact.\n* Financial impact.\n* Burden of the caregivers."}], 'secondaryOutcomes': [{'measure': 'Use of on-demand treatments for HAE attacks', 'timeFrame': 'The survey will focus on HAE attacks that have occurred within the last 12 months.', 'description': 'The survey will collect data to for the following:\n\n* To estimate the number of patients that delay or do not use injectable on-demand treatments for HAE.\n* To identify the reasons why patients, delay or do not use injectable on-demand treatments for HAE attacks.\n* To study the potential benefits of introducing an oral on-demand treatment for HAE attacks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['survey', 'on-demand treatment', 'hereditary angioedema', 'burden', 'caregivers', 'quality of life'], 'conditions': ['Hereditary Angioedema (HAE)']}, 'descriptionModule': {'briefSummary': "The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The online survey assesses various aspects of HAE and in particular the burden of HAE from the patients' and caregivers' perspectives.", 'detailedDescription': 'The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The study will also explore the burden related to the administration of intravenous or subcutaneous on-demand treatments. The study was designed to collect data concerning the burden of HAE in patients with HAE (during HAE attacks and between attacks) and in caregivers. The online survey will collect data to describe the characteristics of patients with HAE, the disease characteristics, details concern various aspects of HAE attacks, and the burden of HAE in patients and their caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HAE', 'genderDescription': 'All patients, irrespective of their gender are eligible for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor the patient population:\n\n1. Patients with a confirmed diagnosis of HAE with a deficit in the C1 inhibitor.\n2. Aged ≥12 years\n3. Having consulted for HAE in the last 3 months and with a medical file.\n\nFor the caregiver population:\n\n1\\. A person identified by the patient as part of their support group and who provides support with the management of the patients HAE (including family members, friends, spouse, etc.)\n\nExclusion Criteria:\n\nFor the patient population:\n\n1. Opposes to participating in the study.\n2. Patients is under guardianship or deprived of their liberty.'}, 'identificationModule': {'nctId': 'NCT06806618', 'acronym': 'ECRINS', 'briefTitle': 'HAE Burden and Crisis Management', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Survey Evaluating the Burden and Management of HAE Crises by Patients and Caregivers', 'orgStudyIdInfo': {'id': '3824.0394'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with HAE', 'description': 'Patients will complete an online survey.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence Bouillet, Professor', 'role': 'CONTACT', 'email': 'LBouillet@chu-grenoble.fr', 'phone': '+33 (0)476767640'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Laurence Bouillet, Professor', 'role': 'CONTACT', 'email': 'LBouillet@chu-grenoble.fr', 'phone': '+33 (0)476767640'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}