Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT04489160
Status:
UNKNOWN
Last Update Posted:
2021-09-13
First Post:
2020-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D054179', 'term': 'Angioedemas, Hereditary'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C469952', 'term': 'SERPING1 protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapy Intensity Level (TIL) Scale', 'timeFrame': 'First four ICU days', 'description': 'TIL differentiated for various treatment modalities aimed at prevention or control of raised Intracranial Pressure (ICP) and/or for CPP management (0 to 38 points)'}, {'measure': 'Glasgow Outcome Scale Extended (GOSE)', 'timeFrame': 'At 6 months after trauma', 'description': 'Functional outcome (minimum score = 1, maximum score = 8)'}, {'measure': 'Complication rate', 'timeFrame': 'Up to 1 year', 'description': 'Adverse and serious adverse events related possibly related to study medication'}], 'secondaryOutcomes': [{'measure': 'Intracranial pressure (ICP) burden', 'timeFrame': 'First four ICU days', 'description': 'Minutes of ICP\\>20 mm Hg'}, {'measure': 'CT scan midline shift', 'timeFrame': 'Up to 1 year', 'description': 'in mm'}, {'measure': 'Mortality', 'timeFrame': 'Up to 1 year after trauma'}, {'measure': 'Glasgow Outcome Scale Extended (GOSE)', 'timeFrame': 'At discharge (an average of 14 days), 3 and 12 months after trauma', 'description': 'Functional outcome (minimum score = 1, maximum score = 8)'}, {'measure': 'QoLiBri', 'timeFrame': 'At 3, 6 and 12 months after trauma', 'description': 'Quality of Life'}, {'measure': 'SF-36', 'timeFrame': 'At 3, 6 and 12 months after trauma', 'description': 'Health-related quality of life'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'At 6 and 12 months after trauma', 'description': 'Health-related quality of life'}, {'measure': 'ICU length of stay', 'timeFrame': 'Up to 1 year', 'description': 'in days'}, {'measure': 'Ventilator days', 'timeFrame': 'Up to 1 year', 'description': 'in days'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Up to 1 year', 'description': 'in days'}, {'measure': 'Hospital disposition', 'timeFrame': 'Up to 1 year', 'description': 'Discharged to home, rehabilitation or nursery home'}, {'measure': 'UCH-L1 and GFAP biomarkers', 'timeFrame': 'Baseline (Before adminstration of investigational product ) and 6, 12, 24, 48, 72 and 96 hours after adminstration of investigational product'}, {'measure': 'Complement activation', 'timeFrame': 'Baseline (Before adminstration of investigational product ) and 6, 12, 24, 48, 72 and 96 hours after adminstration of investigational product', 'description': 'WIESLAB, C3b/C, C4b/C, C5b-9 ELISA assays, CH50/AC50'}, {'measure': 'Coagulation cascade activation', 'timeFrame': 'Baseline (Before adminstration of investigational product ) and 6, 12, 24, 48, 72 and 96 hours after adminstration of investigational product', 'description': 'PT, aPPT, PLT, D-dimer, fibrinogen'}, {'measure': 'Inflammatory markers', 'timeFrame': 'Baseline (Before adminstration of investigational product ) and 6, 12, 24, 48, 72 and 96 hours after adminstration of investigational product', 'description': 'TNF-alpha, intraleukins'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'C1-inhibitor', 'Neuroinflammation', 'Efficacy', 'Safety'], 'conditions': ['Traumatic Brain Injury', 'Trauma, Head']}, 'referencesModule': {'references': [{'pmid': '24489093', 'type': 'BACKGROUND', 'citation': 'Fluiter K, Opperhuizen AL, Morgan BP, Baas F, Ramaglia V. Inhibition of the membrane attack complex of the complement system reduces secondary neuroaxonal loss and promotes neurologic recovery after traumatic brain injury in mice. J Immunol. 2014 Mar 1;192(5):2339-48. doi: 10.4049/jimmunol.1302793. Epub 2014 Jan 31.'}, {'pmid': '34863258', 'type': 'DERIVED', 'citation': 'van Erp IAM, van Essen TA, Fluiter K, van Zwet E, van Vliet P, Baas F, Haitsma I, Verbaan D, Coert B, de Ruiter GCW, Moojen WA, van der Jagt M, Peul WC. Safety and efficacy of C1-inhibitor in traumatic brain injury (CIAO@TBI): study protocol for a randomized, placebo-controlled, multi-center trial. Trials. 2021 Dec 4;22(1):874. doi: 10.1186/s13063-021-05833-1.'}]}, 'descriptionModule': {'briefSummary': 'Severe Traumatic Brain Injury (s-TBI) is a major cause of death and disability across all ages. Besides the primary impact, the pathophysiologic process of major secondary brain damage consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system is therefore considered to be a potentially important new treatment for TBI, as has been shown in animal studies. This trial aims to study the safety and efficacy of C1-inhibitor compared to placebo in TBI patients. By temporarily blocking the complement system we hypothesize limitation of secondary brain injury and more favourable clinical outcome for TBI patients due to a decrease in the posttraumatic neuroinflammatory response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at admission ≥ 18 years and \\< 65 years;\n* Clinical diagnosis of traumatic brain injury with GCS \\< 13 (with intracranial deviations);\n* Catheter placement for monitoring and management of increased ICP for at least 24 hours;\n\nExclusion Criteria:\n\n* A clear, non-traumatic cause of low GCS (e.g. toxic, cardial) on admission;\n* Not expected to survive more than 24 hours after admission;\n* Brain death on arrival in the participating centers;\n* Severe pre-trauma disability, defined as being dependent on other people;\n* Known prior history of sensibility to blood products or Cinryze;\n* Patients with a history of hereditary angioedema;\n* Patients with a history of thrombosis;\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT04489160', 'acronym': 'CIAO@TBI', 'briefTitle': 'Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Severe Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'NL7255105823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C1-inhibitor', 'description': 'One dose 6000 IU C1-inhibitor intravenously', 'interventionNames': ['Drug: C1 Inhibitor, Human']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'C1 Inhibitor, Human', 'type': 'DRUG', 'otherNames': ['Cinryze'], 'description': '6000 IU C1-INH', 'armGroupLabels': ['C1-inhibitor']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wilco Peul', 'role': 'CONTACT'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Rotterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wilco Peul', 'role': 'CONTACT'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wilco Peul', 'role': 'CONTACT'}], 'facility': 'Haaglanden Medisch Centrum', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}], 'centralContacts': [{'name': 'Inge van Erp, BSc', 'role': 'CONTACT', 'email': 'i.a.m.van_erp@lumc.nl', 'phone': '+31(0)715262109'}], 'overallOfficials': [{'name': 'Wilco Peul, MD, MPH, PhD, MBa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Netherlands Brain Foundation', 'class': 'OTHER'}, {'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'wcpeul', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}