Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01503567
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2012-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Algeria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], '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'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2012-01-02', 'studyFirstSubmitQcDate': '2012-01-02', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder)', 'timeFrame': 'After 6 months (recruitment and data collection)'}, {'measure': 'Clinical (using Haemophilia joint score) and radiological (using Pettersson score) orthopaedic status of defined joints: Elbow, knees and ankles in relation to haemophilia A or B', 'timeFrame': 'After 6 months (recruitment and data collection)'}], 'secondaryOutcomes': [{'measure': 'Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores', 'timeFrame': 'After 6 months (recruitment and data collection)'}, {'measure': 'Usage of anti haemophilic treatment in IU/kg', 'timeFrame': 'During the last year preceding patient recruitment'}, {'measure': 'Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire', 'timeFrame': 'After 6 months (recruitment and data collection)'}, {'measure': 'Economic aspects of the management of haemophiliacs and its burden on patient/family and community resources', 'timeFrame': 'After 6 months (recruitment and data collection)'}, {'measure': "Living characteristics of the patient's household", 'timeFrame': 'After 6 months (recruitment and data collection)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A', 'Haemophilia A With Inhibitors', 'Haemophilia B', 'Haemophilia B With Inhibitors']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Gupta N, Belhani M, Benbouzid A, Andaloussi M El, Maani K, Mahlangu J, Wali Y, Saad HA, Fegoun SB el. The Haemocare Protocol - A composite method to measure the disease burden from Haemophilia in developing countries. European Hematology Association 2013; Country: Sweden City: Stockholm'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients at least 6 years old with severe congenital haemophilia A or B (FVIII or FIX activities below 1% or level below 1U dL\\^-1) without inhibitor or with inhibitors against FVIII or FIX', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study\n* Male patients at least 6 years old with diagnosis of severe congenital haemophilia A or B with or without inhibitors\n* Patients receiving on demand replacement factors/bypassing agents therapy\n\nExclusion Criteria:\n\n* Clinically relevant coagulation disorders other than congenital haemophilia A or B\n* Patients on currently active treatment for HCV (Hepatitis C Virus) or HIV (Human Immune Deficiency Virus) infections"}, 'identificationModule': {'nctId': 'NCT01503567', 'acronym': 'HAEMOcare', 'briefTitle': 'Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries', 'orgStudyIdInfo': {'id': 'HAEM-3971'}, 'secondaryIdInfos': [{'id': 'U1111-1124-6665', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects 6 to 18 years old without inhibitors', 'interventionNames': ['Other: No treatment given']}, {'label': 'Subjects 6 to 18 years old with inhibitors', 'interventionNames': ['Other: No treatment given']}, {'label': 'Subjects above18 years old without inhibitors', 'interventionNames': ['Other: No treatment given']}, {'label': 'Subjects above 18 years old with inhibitors', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'Subject will only fill out a questionaire', 'armGroupLabels': ['Subjects 6 to 18 years old with inhibitors', 'Subjects 6 to 18 years old without inhibitors', 'Subjects above 18 years old with inhibitors', 'Subjects above18 years old without inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560001', 'city': 'Bangalore', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '20000', 'city': 'Casablanca', 'country': 'Morocco', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}, {'city': 'Muscat', 'country': 'Oman', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 23.58413, 'lon': 58.40778}}, {'zip': '2146', 'city': 'Sandton', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.104, 'lon': 28.054}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}