Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT01623960
Status:
UNKNOWN
Last Update Posted:
2012-06-20
First Post:
2012-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Adult Patients With Severe Haemophilia in Turkey
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-17', 'studyFirstSubmitDate': '2012-06-17', 'studyFirstSubmitQcDate': '2012-06-17', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe haemophilia', 'quality of life'], 'conditions': ['Haemophilia']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to evaluate the overall quality of life in adult patients with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and to assess the impact of certain disease and drug related factors (treatment modality, presence of viral disease, inhibitor, etc.) on the quality of life.', 'detailedDescription': 'Haemophilia is an inherited bleeding disorder affecting one in 10000 male births worldwide. People with severe haemophilia usually suffer from recurrent life threatening bleeds (e.g. into the brain, digestive system or abdomen) and/or disabling degenerative disease of weight bearing joints (e.g. knees, elbows and ankles)resulting from haemorrhage into the joints. Daily activities of people with haemophilia has been shown to be dramatically hampered by the resultant joint damage. Evaluation of quality of life issues in people with severe haemophilia would help to create awareness of their problems and limitations. This would also set up the scene for developing policies to improve the treatment options/facilities and social life of the patients. Current study aims to assess the quality of life of adult patients with severe haemophilia in a developing country (Turkey) by using a validated Quality of Life Questionnaire (Turkish version of Haem-A-QoL).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male patient with severe haemophilia followed at 10 different haemophilia centers in Turkey', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age equal or greater than 18 years\n* male gender\n* factor VIII or IX level equal or below 1%\n* patients that are willing to participate and have given a written consent\n\nExclusion Criteria:\n\n* age less than 18 years\n* females\n* factor levels above 1%'}, 'identificationModule': {'nctId': 'NCT01623960', 'acronym': 'TurkHaemQoL', 'briefTitle': 'Quality of Life in Adult Patients With Severe Haemophilia in Turkey', 'organization': {'class': 'OTHER', 'fullName': 'Turkish Society of Hematology'}, 'officialTitle': 'A Nationwide Multicenter Study on the Quality of Life in Adult Patients With Severe Haemophilia in Turkey', 'orgStudyIdInfo': {'id': 'THD-HAEM-QoL'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'M.Cem Ar, MD, PhD', 'role': 'CONTACT', 'email': 'mcemar68@yahoo.com', 'phone': '+905326818890'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkish Society of Hematology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Member, Subcommittee of Haemophilia, Turkish Society of Haematology', 'investigatorFullName': 'M. Cem Ar', 'investigatorAffiliation': 'Turkish Society of Hematology'}}}}