Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT00284193
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2006-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2006-01-17', 'studyFirstSubmitQcDate': '2006-01-29', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Coagulation Studies', 'timeFrame': '0-24 HOURS', 'description': 'cbc fibrinogen and D-dimer were assessed pre and post therapy, thrombin generation was assayed when possible after 1-2 hours'}], 'primaryOutcomes': [{'measure': 'Hemostasis achieved post therapy', 'timeFrame': '6-24 hours', 'description': 'Following acute bleeding therapy hemostasis was defined as good, partial or non-satisfactory'}, {'measure': 'Safety', 'timeFrame': '0-24 HOURS', 'description': 'Following therapy presence of any adverse events, especially thromboembolic complications was assessed'}], 'secondaryOutcomes': [{'measure': 'Time to Hemostasis', 'timeFrame': '0-24 HOURS', 'description': 'Following therapy patients documented time to "GOOD" response'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemophilia A']}, 'descriptionModule': {'briefSummary': 'Patients with severe hemophilia and inhibitors can be treated effectively by Activated Prothrombin Complex Concentrates (APCC, eg. FEIBA) or High dose recombinant factor VIIa (rFVIIa). Rarely, such patients develop refractoriness to these products for whom therapy with sequential FEIBA and rFVIIa has been recently suggested.\n\nThe impetus for the present report was a hemophilia A patient with high titer inhibitor (1300BU) who had life threatening hematuria that was resistant to repeated doses of 400µg/kg rFVIIa up to a cumulative dose of 1200 µg/kg given over 6-9 hours.\n\nThrombin generation (TG) tested in vitro was consistent with resistance to high concentrations of rFVIIa but yielded good response to combinations of low doses of rFVIIa+FEIBA. In a desperate attempt to control the bleeding, concomitant therapy of 25 U/kg FEIBA and 40µg/kg rFVIIa was infused and resulted in arrest of bleeding within minutes. Over a span of about one year the patient has been successfully treated by this combination for more than 200 bleeding episodes in muscles and joints.', 'detailedDescription': "Inhibitor patients with HR inhibitors were eligible for study enrollment. After consent blood was drawn and ex- vivo spiked with rFVIIa/FEIBA and combinations, assayed by thrombin generation tests.\n\nThe combination yielding sufficient hemostasis was depicted for patients' therapy of future bleeding episodes.\n\nFollowing actual therapy hemostasis and safety parameters were monitored."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemophilia patients with inhibitors\n* Patients signing informed consent\n\nExclusion Criteria:\n\n* Patients under 16 or above 65\n* Patients with allergic reaction or adverse events in previous use the concentrates\n* Patients with high risk of thrombosis'}, 'identificationModule': {'nctId': 'NCT00284193', 'briefTitle': 'Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII', 'orgStudyIdInfo': {'id': 'SHEBA-05-3768-UM-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'feiba-VIIa, hemophilia A-inhibitor therapy', 'description': 'COMBINED PATIENT- TAILORED THERAPY WITH CONCOMITANT ADMINISTRATION OF BOTH DRUGS , FOLLOWING EX VIVO THROMBIN GENERATION PREDICTING ASSAYS', 'interventionNames': ['Drug: rFVIIa-FEIBA therapy for hemophilia A inhibitors', 'Drug: FEIBA- Activated Prothrombin Complexes']}], 'interventions': [{'name': 'rFVIIa-FEIBA therapy for hemophilia A inhibitors', 'type': 'DRUG', 'otherNames': ['NOVOSEVEN', 'APCC'], 'description': 'DOses tailored per ex vivo spiking thrombin generation', 'armGroupLabels': ['feiba-VIIa, hemophilia A-inhibitor therapy']}, {'name': 'FEIBA- Activated Prothrombin Complexes', 'type': 'DRUG', 'armGroupLabels': ['feiba-VIIa, hemophilia A-inhibitor therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Uri Martinowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Uri Martinowitz', 'investigatorFullName': 'Prof. Uriel Martinowitz', 'investigatorAffiliation': 'Sheba Medical Center'}}}}