Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 6:39 PM
Study NCT ID:
NCT01082406
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2010-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C521905', 'term': 'recombinant factor XIII-A2'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2010-03-05', 'studyFirstSubmitQcDate': '2010-03-05', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay', 'timeFrame': 'after 4 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events (serious and non-serious)', 'timeFrame': 'over 8 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Congenital FXIII Deficiency', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) between 18.5 and 30 kg/m2\n* Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician\n* Non-smokers\n\nExclusion Criteria:\n\n* Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician\n* Blood transfusion within 3 months of trial start\n* Positive for hepatitis B or C infection\n* Positive for Human Immunodeficiency Virus (HIV) infection\n* Excessive consumption of a diet deviating from a normal diet as judged by the physician\n* Blood or plasma donation within the last 3 months prior to trial start\n* Subjects with any history of migraine'}, 'identificationModule': {'nctId': 'NCT01082406', 'briefTitle': 'Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)', 'orgStudyIdInfo': {'id': 'NN1841-3788'}, 'secondaryIdInfos': [{'id': '2009-016438-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1113-2008', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trial part 1', 'interventionNames': ['Drug: catridecacog']}, {'type': 'EXPERIMENTAL', 'label': 'Trial part 2', 'interventionNames': ['Drug: recombinant factor XIII']}], 'interventions': [{'name': 'catridecacog', 'type': 'DRUG', 'description': 'Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.', 'armGroupLabels': ['Trial part 1']}, {'name': 'recombinant factor XIII', 'type': 'DRUG', 'description': 'Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv.', 'armGroupLabels': ['Trial part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], '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'}}}}