Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-04-14 @ 1:43 PM
Study NCT ID:
NCT02207218
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan
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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Adverse Events (AEs)', 'timeFrame': 'Week 0- 104'}], 'secondaryOutcomes': [{'measure': 'Frequency of Adverse Reactions (ARs)', 'timeFrame': 'Week 0- 104'}, {'measure': 'Frequency of Serious Adverse Events (SAEs)', 'timeFrame': 'Week 0- 104'}, {'measure': 'Frequency of Serious Adverse Reactions (SARs)', 'timeFrame': 'Week 0- 104'}, {'measure': 'Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively', 'timeFrame': 'Week 0- 104'}, {'measure': 'Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None', 'timeFrame': 'Week 0- 104'}, {'measure': 'Annualised bleeding rate for patients using NovoEight® for preventive regimen', 'timeFrame': 'Week 0- 104'}, {'measure': 'Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)', 'timeFrame': 'Week 0- 104'}, {'measure': 'Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)', 'timeFrame': 'Week 0- 104'}, {'measure': 'Consumption of NovoEight® per month (IU/kg BW/month) for prevention', 'timeFrame': 'Week 0- 104'}, {'measure': 'Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen', 'timeFrame': 'Week 0- 104'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NovoEight® in prevention, treatment of bleeds and prevention of bleeds during and after surgery in previously treated patients (PTPs) and previously untreated patients (PUPs) with haemophilia A in routine clinical setting in Japan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol\n* Male and female patients with the diagnosis of haemophilia A\n* Age range is 0 year and above\n* A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician\n\nExclusion Criteria:\n\n* Known or suspected allergy to study product(s) or related products\n* Previous participation in this study. Participation is defined as informed consent obtained\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation'}, 'identificationModule': {'nctId': 'NCT02207218', 'briefTitle': 'To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan', 'orgStudyIdInfo': {'id': 'NN7008-4105'}, 'secondaryIdInfos': [{'id': 'U1111-1144-8212', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'NovoEight®', 'interventionNames': ['Drug: turoctocog alfa']}], 'interventions': [{'name': 'turoctocog alfa', 'type': 'DRUG', 'description': 'No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician.', 'armGroupLabels': ['NovoEight®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1670035', 'city': 'Suginami-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '167-0035', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], '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'}}}}