Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT06358703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-13
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585343', 'term': 'caplacizumab'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma will be held in a biobank'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-10', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Silent cerebral infarction', 'timeFrame': '12 months', 'description': 'Silent cerebral infarction (primary endpoint) - SCI is derived from quantitation (number and total volume) of ischemic\n\n(infarct-like) lesions shown as foci of T2 and FLAIR hyperintensity. SCI is diagnosed if the participant has an infarct like\n\nlesion, at least 3 mm, with normal neurologic examination or an abnormality on examination that is not explained by the\n\nlocation of the brain lesion. We have assembled a panel of 3 neuroradiologists headed by Dr. Doris Lin. Each MRI will be\n\nread by 2 radiologists. A third reviewer will serve as a tie breaker in case of disagreement.'}, {'measure': 'Cognitive impairment', 'timeFrame': '12 months', 'description': 'Cognitive impairment (co-primary endpoint) - measured using NIH ToolBox Cognition Battery. Mild and major cognitive impairment are\n\ndefined as T scores that are 1-2 SD below mean and \\> 2SD below mean for any domain, respectively'}], 'secondaryOutcomes': [{'measure': 'Depression scores on BDI-II', 'timeFrame': '12 months'}, {'measure': 'SF-36 scores for quality of life', 'timeFrame': '12 months'}, {'measure': 'Patient reported cognitive performance', 'timeFrame': '12 months', 'description': '(PROMIS Cognitive Function - Short form 8a)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TTP', 'iTTP', 'aTTP', 'Cognitive impairment'], 'conditions': ['Immune Thrombotic Thrombocytopenia']}, 'descriptionModule': {'briefSummary': '1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.\n2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.\n3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)\n4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with iTTP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Confirmed iTTP based on ADAMS13 activity \\< 10 % (or 10-20% with positive inhibitor or antibody) during an acute iTTP episode\n3. Only 1 episode of iTTP that was treated with plasma exchange and caplacizumab started within 3 days of diagnosis (or if more than 1 episode, then all episodes treated with plasma exchange and caplacizumab started within 3 days of diagnosis)\n\nExclusion Criteria:\n\n1. Any contraindication for MRI (metallic implants, shrapnel, MRI incompatible stents, etc)\n2. Unable to speak, read or understand instructions in English (for NIH ToolBox)\n3. Combination of iTTP episodes treated without caplacizumab or with caplacizumab.\n4. Caplacizumab started at \\>= 4 days from diagnosis or for refractory iTTP'}, 'identificationModule': {'nctId': 'NCT06358703', 'acronym': 'NeST', 'briefTitle': 'Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors', 'organization': {'class': 'OTHER', 'fullName': 'US Thrombotic Microangiopathy Alliance'}, 'officialTitle': 'Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors', 'orgStudyIdInfo': {'id': 'P400'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'interventionNames': ['Drug: Caplacizumab']}, {'label': 'Controls'}], 'interventions': [{'name': 'Caplacizumab', 'type': 'DRUG', 'description': 'Early Caplacizumab use', 'armGroupLabels': ['Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43125', 'city': 'Groveport', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Clare Martin', 'role': 'CONTACT', 'email': 'Clare@ustma.org', 'phone': '6149994900'}], 'facility': 'USTMA', 'geoPoint': {'lat': 39.8784, 'lon': -82.88379}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Thrombotic Microangiopathy Alliance', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}