Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-05 @ 12:01 AM
Study NCT ID:
NCT02263066
Status:
COMPLETED
Last Update Posted:
2015-07-17
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of regular prophylaxis', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Prophylaxis infusion dose', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Percentage of rFVIII usage in prophylaxis', 'timeFrame': 'Up to 1.5 years'}], 'secondaryOutcomes': [{'measure': 'Bleeding frequency', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Joint radiographic score', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Joint physical examination score', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Quality of life by questionnaire', 'timeFrame': 'Up to 1.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '28532239', 'type': 'DERIVED', 'citation': 'Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu V, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Status and trend analysis of prophylactic usage of recombinant factor VIII in Chinese pediatric patients with hemophilia A: ReCare - a retrospective, phase IV, non-interventional study. Curr Med Res Opin. 2017 Sep;33(9):1571-1578. doi: 10.1080/03007995.2017.1333489. Epub 2017 Jun 21.'}, {'pmid': '28326849', 'type': 'DERIVED', 'citation': 'Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu W, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Long-term efficacy and safety of prophylaxis with recombinant factor VIII in Chinese pediatric patients with hemophilia A: a multi-center, retrospective, non-interventional, phase IV (ReCARE) study. Curr Med Res Opin. 2017 Jul;33(7):1223-1230. doi: 10.1080/03007995.2017.1310720. Epub 2017 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'About 300 at most hemophilia boys (2-\\<18 years) in the representative hemophilia treatment centers (HTCs) with available medical data record, having received rFVIII contained regular prophylaxis between Nov. 1st 2007 and May 31st 2013 will be enrolled from about 15 centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, 2-\\<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%\\[10\\] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that \\<2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis.\n\nAvailable patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate\n\nExclusion Criteria:\n\n* Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)'}, 'identificationModule': {'nctId': 'NCT02263066', 'acronym': 'ReCARE', 'briefTitle': 'Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis', 'orgStudyIdInfo': {'id': '17653'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013', 'interventionNames': ['Biological: BAY14-2222_Kogenate-FS FVIII']}], 'interventions': [{'name': 'BAY14-2222_Kogenate-FS FVIII', 'type': 'BIOLOGICAL', 'description': "Depends on Doctor's decision", 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'China'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}