Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT00606060
Status:
COMPLETED
Last Update Posted:
2010-04-13
First Post:
2008-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAY14-2222 Continuous Infusion in Surgeries
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': 'C078147', 'term': 'F8 protein, human'}, {'id': 'C414350', 'term': 'BAY 14-2222'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2008-01-21', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Evaluate the safety of rFVIII-FS.', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemophilia,', 'Continuous Infusion'], 'conditions': ['Hemophilia']}, 'descriptionModule': {'briefSummary': 'Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe hemophilia A (FVIII:C \\</=1%)\n* No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay \\< 0.6 BU)\n* Elective major surgery requiring at least 6 days of rFVIII-FS therapy\n* Subjects should have been previously treated with FVIII concentrates for at least 150 exposure days. Previous treatment could have been with any type of rFVIII or with plasma-derived FVIII concentrate or cryoprecipitate\n\nExclusion Criteria:\n\n* Abnormal renal function (serum creatinine \\>1.3 mg/dL)\n* Any treatments, which may change the clearance of FVIII (dialysis, plasma exchange)\n* Anemia (hemoglobin \\<11 g/dL)\n* Known AIDS (HIV seropositive patients may be enrolled)\n* Active liver disease (transaminases \\> 5 times the upper limit of normal)\n* History of severe reaction to FVIII concentrates\n* Interferon treatment within the last 3 months\n* Thrombocytopenia (\\< 100,000 platelets/mm3) or other known hematological/bleeding problems other than hemophilia A\n* Intake of other investigational drugs within 1 month prior to study entry\n* Need for pre-medication for FVIII infusions (e.g. antihistamines)\n* Diastolic blood pressure \\>100 mm/Hg, which could not be controlled with antihypertensive medications'}, 'identificationModule': {'nctId': 'NCT00606060', 'briefTitle': 'BAY14-2222 Continuous Infusion in Surgeries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Safety and Efficacy of Continuous Infusion of Recombinant Factor VIII - Sucrose-formulated (BAY 14 2222) Concentrate in Patients With Hemophilia A Undergoing Major Elective Surgery.', 'orgStudyIdInfo': {'id': '11486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Kogenate (BAY14-2222)']}], 'interventions': [{'name': 'Kogenate (BAY14-2222)', 'type': 'DRUG', 'description': '100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Bayer HealthCare AG'}}}}