Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 7:56 PM
Study NCT ID:
NCT04584892
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities
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': 'C577506', 'term': 'recombinant factor VIII N8'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)', 'timeFrame': 'Baseline (week 0)', 'description': 'Count'}], 'secondaryOutcomes': [{'measure': 'Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW', 'timeFrame': 'Final visit (12 months)', 'description': 'Count'}, {'measure': 'Change of PPX regimen: YES/NO', 'timeFrame': '12 months after treatment initiation', 'description': 'Count (participants who have changed regimen or not)'}, {'measure': 'Reported reasons for change of PPX regimens', 'timeFrame': 'Final visit (12 months)', 'description': "Count (reasons according to the predefined list, see below)\n\nIndividual reported reasons for switch will be selected among the following predefined:\n\n1. to improve articular protection\n2. due to bleedings\n3. due to patients' needs, including: physical inactivity, work, recreational activity, travel, other."}, {'measure': "Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire", 'timeFrame': 'Final visit (12 months) vs Baseline (week 0)', 'description': 'Points\n\nThe following sections of the BHERO questionnaire will be used:\n\n1. Haemophilia Activities List (HAL: measures the impact of haemophilia on self-perceived functional abilities in patients (42 questions in 7 domains). Scores from 1 (worst) to 6 (best). The final score is the sum of all the scores.)\n2. Recreational and sport activities\n3. Brief pain inventory, exploring the presence and intensity of physical pain, and its impact on performance of daily activities.\n4. International Physical Activities questionnaire (IPAQ) score (Score\\<700 = Inactive Patient, Score 700 to 2519 = Sufficiently active patient, Score ≥ 2520 = Active or very active patient.'}, {'measure': 'Difference in circulating turoctocog alfa levels', 'timeFrame': 'Final visit (12 months) vs Baseline (week 0)', 'description': 'IU/mL\n\nBefore 12 months visit, monitoring will be reported only if measured in clinical practice due to bleedings or other clinical reasons.'}, {'measure': 'Individual Annual Bleeding Rate (ABR)', 'timeFrame': 'From baseline to final visit (12 months)', 'description': 'Count'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemophilia A']}, 'descriptionModule': {'briefSummary': 'This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n* Male or female, age above or equal to 12 years at the time of signing informed consent.\n* Haemophilia A (any severity), needing prophylactic therapy (with the usual recommended doses).\n* Decision to treat with turoctocog alfa, made by the treating Physician and the subject/Legally Acceptable Representative (LAR) based on local label before and independently from the decision to include the subject in this study.\n\nExclusion Criteria:\n\n* Previous participation in this study, defined as previously signed informed consent;\n* Presence of other coagulation disorders;\n* Presence of any inhibitor;\n* Mental problems, poor compliance, linguistic barriers or other conditions which can impede the understanding of the study aims and the participation to it.'}, 'identificationModule': {'nctId': 'NCT04584892', 'acronym': 'THIRd', 'briefTitle': 'Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (THIRd). An Observational, Prospective, Multicentre, Cohort Study on Italian Patients With Haemophilia A in Prophylaxis Treatment With Turoctocog Alfa Under Current Clinical Conditions', 'orgStudyIdInfo': {'id': 'NN7008-4655'}, 'secondaryIdInfos': [{'id': 'U1111-1247-5494', 'type': 'OTHER', 'domain': 'World Health Organisation (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Haemophilia A', 'description': 'Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy.', 'interventionNames': ['Drug: Turoctocog alfa']}], 'interventions': [{'name': 'Turoctocog alfa', 'type': 'DRUG', 'description': 'Patients will be treated with commercially available NovoEight® (turoctocog alfa) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available NovoEight® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.', 'armGroupLabels': ['Haemophilia A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20124', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '31033', 'city': 'Castelfranco Veneto', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.67146, 'lon': 11.92755}}, {'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '47521', 'city': 'Cesena', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.1391, 'lon': 12.24315}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20089', 'city': 'Milan', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80147', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '36100', 'city': 'Vicenza', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure 1452', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}