Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT01538160
Status:
UNKNOWN
Last Update Posted:
2012-02-23
First Post:
2012-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005173', 'term': 'Factor XI Deficiency'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103587', 'term': 'recombinant FVIIa'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-22', 'studyFirstSubmitDate': '2012-01-19', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency', 'timeFrame': '1 week', 'description': 'End point to be assessed the degree of bleeding following major operation under rFVIIa'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recombinant factor VIIa', 'factor XI deficiency'], 'conditions': ['Hemophilia C']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Salomon et al presented at ASH 2008 entitled'}]}, 'descriptionModule': {'briefSummary': 'Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.', 'detailedDescription': 'Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with severe factor XI deficiency who will give informed consent to participate in the study\n\nExclusion Criteria:\n\n* patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke\n* Patients who required aorto-coronary bypass or any vascular surgery'}, 'identificationModule': {'nctId': 'NCT01538160', 'acronym': 'rFVIIa', 'briefTitle': 'A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'orgStudyIdInfo': {'id': 'SHEBA-11-8657-OS-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant factor VIIa', 'type': 'DRUG', 'description': 'single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'Ophira salomon, MD', 'role': 'CONTACT', 'email': 'ophiras@sheba.health.gov.il', 'phone': '01197235302104'}, {'name': 'Uri Seligsohn, MD', 'role': 'CONTACT', 'email': 'Uri.Seligson@sheba.health.gov.il', 'phone': '01197235302104'}, {'name': 'Uri Seligsohn, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ophira Salomon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ophira Salomon', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Tel Hashomer, Ramat-Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center'}], 'centralContacts': [{'name': 'Ophira Salomon, MD', 'role': 'CONTACT', 'email': 'ophiras@sheba.health.gov.il', 'phone': '97235302104'}, {'name': 'Uri Seligsohn, MD', 'role': 'CONTACT', 'email': 'Uri.Seligson@sheba.health.gov.il', 'phone': '97235302104'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}