Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-28 @ 7:19 PM
Study NCT ID:
NCT01386268
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2011-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kogenate FS Regulatory Post-Marketing Surveillance
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': 'D005169', 'term': 'Factor VIII'}, {'id': 'C078147', 'term': 'F8 protein, human'}, {'id': 'C414350', 'term': 'BAY 14-2222'}], 'ancestors': [{'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2011-06-14', 'studyFirstSubmitQcDate': '2011-06-30', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables will be summarized using descriptive statistics based on adverse events collection', 'timeFrame': 'Up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Type of the treatment (prophylaxis, on demand, surgery)', 'timeFrame': 'Initial visit and 6 month f/u or at the end of the observation visit'}, {'measure': 'Total consumption of FVIII', 'timeFrame': 'Initial visit and 6 month f/u or at the end of the observation visit'}, {'measure': 'Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)', 'timeFrame': 'Initial visit, 6 month follow-up visit and 12 month follow-up visit'}, {'measure': 'General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient', 'timeFrame': '6 month f/u or at the end of observation visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kogenate FS', 'Hemophilia A'], 'conditions': ['Hemophilia A']}, 'descriptionModule': {'briefSummary': 'To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.\n\nThe observation period for each patient is up to 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hemophilia A in Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of hemophilia A\n* Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS\n* Signed the informed consent form to participate in this study.\n* For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available\n* For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available\n* For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA\n* Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.'}, 'identificationModule': {'nctId': 'NCT01386268', 'acronym': 'KG0910KR', 'briefTitle': 'Kogenate FS Regulatory Post-Marketing Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'KOGENATE® FS , Local Post Authorization Safety Study', 'orgStudyIdInfo': {'id': '14927'}, 'secondaryIdInfos': [{'id': 'KG0910KR', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)']}], 'interventions': [{'name': 'Recombinant Factor VIII (Kogenate FS, BAY14-2222)', 'type': 'BIOLOGICAL', 'description': 'Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'South Korea'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}