Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 2:13 PM
Study NCT ID:
NCT00922792
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2009-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2009-06-16', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of adverse events', 'timeFrame': 'after 1 and 2 weeks after dosing'}, {'measure': 'Frequency of serious adverse events', 'timeFrame': 'after 1, 2 and 6-10 weeks after dosing'}, {'measure': 'Frequency of MESIs (Medical Event of Special Interest)', 'timeFrame': 'after 1, 2 and 6-10 weeks after dosing'}, {'measure': 'Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa', 'timeFrame': 'after 2 and 6-10 weeks after dosing'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½', 'timeFrame': 'from time of dosing up to 72 hours after the last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A', 'Haemophilia B']}, '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 investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Haemophilia A or B\n* Bodyweight max 100 kg\n* Body Mass Index (BMI) max 30 kg/m2\n* Adequate venous access\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial product(s) or related products (including NovoSeven®)\n* The receipt of any investigational product within 30 days prior to enrolment in this trial\n* Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial\n* The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product\n* Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration\n* Known pseudo tumours\n* Congenital or acquired coagulation disorders other than haemophilia A or B\n* Any major and/or orthopaedic surgery within one month prior to trial start\n* Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)\n* Clinical signs of renal dysfunction\n* Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug\n* Use of non-prescribed opiate substances'}, 'identificationModule': {'nctId': 'NCT00922792', 'briefTitle': 'Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B', 'orgStudyIdInfo': {'id': 'NN7128-3700'}, 'secondaryIdInfos': [{'id': '2009-010080-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: activated recombinant human factor VII, long acting']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: activated recombinant human factor VII, long acting']}], 'interventions': [{'name': 'activated recombinant human factor VII, long acting', 'type': 'DRUG', 'description': 'Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration', 'armGroupLabels': ['A']}, {'name': 'activated recombinant human factor VII, long acting', 'type': 'DRUG', 'description': 'Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours', 'armGroupLabels': ['B']}]}, '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'}}}}