Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-03 @ 12:08 PM
Study NCT ID:
NCT04032002
Status:
UNKNOWN
Last Update Posted:
2019-10-17
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013026', 'term': 'Space Flight'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D001359', 'term': 'Aviation'}, {'id': 'D014186', 'term': 'Transportation'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-16', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare the gene expression of B1 and / or B2 monocyte receptors', 'timeFrame': 'Day 1', 'description': 'compare between patients with hereditary bradykinetic angioedema and control subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hereditary Bradykinetic Angioedema']}, 'descriptionModule': {'briefSummary': 'The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (patients):\n\n* Patient with inherited bradykinic angioedema due to quantitative or qualitative C1-inhibitor deficiencies, regardless of the frequency or severity of seizures and regardless of their background treatment, with the following diagnostic criteria:\n\n * C1-inhibitor rate \\<50% of normal\n * Repeated episodes characteristic of bradykinic angioedema\n * Hereditary nature of the disease.\n* Person who read and understood the newsletter and signed the consent form\n* Person affiliated with a social security scheme\n* Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmatory diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).\n\nInclusion Criteria (volunteers):\n\n* Person affiliated with a social security scheme\n* Person who read and understood the newsletter and signed the consent form\n* Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit)\n\nExclusion Criteria (patients):\n\n* Angioedema crisis less than 1 month old\n* Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.\n* Acute infection in progress, with or without anti-infectious treatment\n* Contraindication to the use of trinitrin:\n\n * Hypersensitivity to nitrates or to any of the excipients\n * shock, severe hypotension,\n * obstructive cardiomyopathy,\n * inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure,\n * intracranial hypertension,\n * patient treated with sildenafil\n* Pregnant or parturient or breastfeeding woman or lack of proven contraception\n* Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship\n* Patient participating or having participated in another therapeutic trial within one week.\n\nExclusion Criteria (volunteers)\n\n* Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.\n* Acute infection in progress, with or without anti-infectious treatment\n* Contraindication to the use of trinitrin:\n\n * Hypersensitivity to nitrates or to any of the excipients\n * shock, severe hypotension,\n * obstructive cardiomyopathy,\n * inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure,\n * intracranial hypertension,\n * patient treated with sildenafil\n* Pregnant or parturient or breastfeeding woman or lack of proven contraception\n* Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship\n* Person participating or having participated in another therapeutic trial within one week."}, 'identificationModule': {'nctId': 'NCT04032002', 'acronym': 'MONOBRAD', 'briefTitle': 'Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema', 'orgStudyIdInfo': {'id': '2018/349/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients hereditary bradykinetic angioedema', 'interventionNames': ['Other: Explorations', 'Other: Blood samples']}, {'type': 'OTHER', 'label': 'healthy volunteers', 'interventionNames': ['Other: Explorations', 'Other: Blood samples']}], 'interventions': [{'name': 'Explorations', 'type': 'OTHER', 'description': 'On Day 1 vascular fonctions explorations performed', 'armGroupLabels': ['Patients hereditary bradykinetic angioedema', 'healthy volunteers']}, {'name': 'Blood samples', 'type': 'OTHER', 'description': 'On Day 1 35ml taken', 'armGroupLabels': ['Patients hereditary bradykinetic angioedema', 'healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David MALLET', 'role': 'CONTACT', 'email': 'secretariat.drc@chu-rouen.fr', 'phone': '0232888265'}, {'name': 'Guillaume ARMENGOL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DRCI', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}