Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00837356
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2009-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
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': 'D005169', 'term': 'Factor VIII'}, {'id': 'C577506', 'term': 'recombinant factor VIII N8'}, {'id': 'C438308', 'term': 'recombinant FVIII, sugar formulated'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2009-02-04', 'studyFirstSubmitQcDate': '2009-02-04', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery of FVIII 30 min after administration, half-life, AUC, and clearance', 'timeFrame': 'at 30 days'}], 'secondaryOutcomes': [{'measure': 'Inhibitor development', 'timeFrame': 'at 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A']}, 'referencesModule': {'references': [{'pmid': '21443634', 'type': 'RESULT', 'citation': 'Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE(R))--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia. 2011 Nov;17(6):854-9. doi: 10.1111/j.1365-2516.2011.02495.x. Epub 2011 Mar 28.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe haemophilia A (FVIII level less than or equal to 1%)\n* Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products\n* HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial\n\nExclusion Criteria:\n\n* Presence of any bleeding disorder in addition to haemophilia A\n* Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor\n* Abnormal renal function tests\n* Known hypersensitivity to Advate®'}, 'identificationModule': {'nctId': 'NCT00837356', 'briefTitle': 'Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A', 'orgStudyIdInfo': {'id': 'NN7008-3522'}, 'secondaryIdInfos': [{'id': '2008-002157-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advate®/turoctocog alfa', 'interventionNames': ['Drug: Advate®', 'Drug: turoctocog alfa']}], 'interventions': [{'name': 'Advate®', 'type': 'DRUG', 'description': 'Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session', 'armGroupLabels': ['Advate®/turoctocog alfa']}, {'name': 'turoctocog alfa', 'type': 'DRUG', 'otherNames': ['recombinant FVIII', 'N8'], 'description': 'After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session', 'armGroupLabels': ['Advate®/turoctocog alfa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10249', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20124', 'city': 'Milan', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], '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'}}}}