Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-28 @ 2:59 AM
Study NCT ID:
NCT01949792
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], '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'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005167', 'term': 'Factor VII'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2013-09-13', 'studyFirstSubmitQcDate': '2013-09-24', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')", 'timeFrame': '10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg'}], 'secondaryOutcomes': [{'measure': 'TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)', 'timeFrame': 'Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A', 'Haemophilia A With Inhibitors', 'Haemophilia B', 'Haemophilia B With Inhibitors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records\n\nExclusion Criteria:\n\n* Congenital or acquired coagulation disorder other than congenital haemophilia A or B\n* Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)\n* Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)\n* Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period'}, 'identificationModule': {'nctId': 'NCT01949792', 'briefTitle': 'A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Open-label Single- and Multiple-dose Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa Following i.v. Administration of One Dose of 270 Microg/kg and Three Doses of 90 Microg/kg in Patients With Haemophilia A or B With or Without Inhibitors', 'orgStudyIdInfo': {'id': 'NN7777-4086'}, 'secondaryIdInfos': [{'id': '2013-000040-26', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1138-2521', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '270 microg/kg rFVIIa', 'description': 'Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours', 'interventionNames': ['Drug: eptacog alfa (activated)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3x90 microg/kg rFVIIa', 'description': 'Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours', 'interventionNames': ['Drug: eptacog alfa (activated)']}], 'interventions': [{'name': 'eptacog alfa (activated)', 'type': 'DRUG', 'description': 'Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)', 'armGroupLabels': ['270 microg/kg rFVIIa']}, {'name': 'eptacog alfa (activated)', 'type': 'DRUG', 'description': 'Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours)', 'armGroupLabels': ['3x90 microg/kg rFVIIa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], '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'}}}}