Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 2:57 AM
Study NCT ID:
NCT01238367
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2010-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
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'}, {'id': 'D005169', 'term': 'Factor VIII'}], 'ancestors': [{'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve', 'timeFrame': 'Infusion, 30 minutes'}, {'measure': 'Incremental recovery', 'timeFrame': 'Infusion, 30 minutes'}, {'measure': 'In vivo t1/2', 'timeFrame': 'Infusion, 30 minutes'}, {'measure': 'Total clearance (CL)', 'timeFrame': 'Infusion, 30 minutes'}], 'secondaryOutcomes': [{'measure': 'Maximal concentration', 'timeFrame': 'at 15 minutes'}, {'measure': 'Area under the curve', 'timeFrame': 'from time zero to last'}, {'measure': 'Number of adverse events', 'timeFrame': 'from day -1 to day 3 (end of trial)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A']}, 'referencesModule': {'references': [{'pmid': '25495795', 'type': 'RESULT', 'citation': 'Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese subjects who have completed NN7008-3543\n* No detectable inhibitors to factor VIII\n\nExclusion Criteria:\n\n* Congenital or acquired coagulation disorders other than haemophilia A\n* Planned surgery during the trial period\n* Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration'}, 'identificationModule': {'nctId': 'NCT01238367', 'briefTitle': 'A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A', 'orgStudyIdInfo': {'id': 'NN7008-3600'}, 'secondaryIdInfos': [{'id': 'U1111-1117-1286', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-101346', 'type': 'OTHER', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'recombinant factor VIII (N8)', 'interventionNames': ['Drug: turoctocog alfa']}], 'interventions': [{'name': 'turoctocog alfa', 'type': 'DRUG', 'otherNames': ['N8', 'recombinant factor VIII'], 'description': 'Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.', 'armGroupLabels': ['recombinant factor VIII (N8)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '173 8606', 'city': 'Itabashi-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '634 8522', 'city': 'Kashihara-shi, Nara', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '371-8511', 'city': 'Maebashi-shi, Gunma', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '160 0023', 'city': 'Shinjuku-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '4208660', 'city': 'Shizuoka-shi, Shizuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '1670035', 'city': 'Suginami-ku, 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'}}}}