Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-01 @ 11:22 AM
Study NCT ID:
NCT00426803
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2007-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
Sponsor:
Organization:
Raw JSON
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Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005 Feb 24;352(8):777-85. doi: 10.1056/NEJMoa042991.'}, {'pmid': '16636233', 'type': 'RESULT', 'citation': 'Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, Begtrup K, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology. 2006 Apr 25;66(8):1175-81. doi: 10.1212/01.wnl.0000208408.98482.99.'}, {'pmid': '17038942', 'type': 'RESULT', 'citation': 'Steiner T, Diringer MN, Schneider D, Mayer SA, Begtrup K, Broderick J, Skolnick BE, Davis SM. Dynamics of intraventricular hemorrhage in patients with spontaneous intracerebral hemorrhage: risk factors, clinical impact, and effect of hemostatic therapy with recombinant activated factor VII. Neurosurgery. 2006 Oct;59(4):767-73; discussion 773-4. doi: 10.1227/01.NEU.0000232837.34992.32.'}, {'pmid': '16552014', 'type': 'RESULT', 'citation': 'Zimmerman RD, Maldjian JA, Brun NC, Horvath B, Skolnick BE. Radiologic estimation of hematoma volume in intracerebral hemorrhage trial by CT scan. AJNR Am J Neuroradiol. 2006 Mar;27(3):666-70.'}, {'pmid': '17290026', 'type': 'RESULT', 'citation': 'Broderick JP, Diringer MN, Hill MD, Brun NC, Mayer SA, Steiner T, Skolnick BE, Davis SM; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Determinants of intracerebral hemorrhage growth: an exploratory analysis. Stroke. 2007 Mar;38(3):1072-5. doi: 10.1161/01.STR.0000258078.35316.30. Epub 2007 Feb 8.'}, {'pmid': '17630481', 'type': 'RESULT', 'citation': 'Diringer MN, Ferran JM, Broderick J, Davis S, Mayer SA, Steiner T, Brun NC, Skolnick BE, Christensen MC. Impact of recombinant activated factor VII on health-related quality of life after intracerebral hemorrhage. Cerebrovasc Dis. 2007;24(2-3):219-25. doi: 10.1159/000104481. Epub 2007 Jun 28.'}, {'pmid': '18580208', 'type': 'RESULT', 'citation': 'Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.'}, {'pmid': '37870112', 'type': 'DERIVED', 'citation': 'Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom\n\nExclusion Criteria:\n\n* Patients with secondary ICH\n* Pre-existing disability\n* Haemophilia'}, 'identificationModule': {'nctId': 'NCT00426803', 'briefTitle': 'Recombinant Factor VIIa in Acute Intracerebral Haemorrhage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage', 'orgStudyIdInfo': {'id': 'F7ICH-1371'}}, 'armsInterventionsModule': {'interventions': [{'name': 'activated recombinant human factor VII', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'VIC 3052', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': 'AB T2N 2T9', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '00014', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': 'SN04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '06126', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '1105', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '308443', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'NE2 4HH', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}