Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT00139828
Status:
COMPLETED
Last Update Posted:
2007-08-30
First Post:
2005-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D005164', 'term': 'Factor IX'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-29', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2007-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of bleeding episodes (efficacy after administration)', 'timeFrame': '24 months'}, {'measure': 'Haematological variables and clinical chemistry (safety)', 'timeFrame': '24 months'}, {'measure': 'Adverse events (safety)', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence of antibodies to factor IX', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['haemophilia B', 'factor IX', 'Product Surveillance, Postmarketing', 'plasma products'], 'conditions': ['Hemophilia B']}, 'descriptionModule': {'briefSummary': 'In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.', 'detailedDescription': "The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden\n* Above the age of six, at the moment of inclusion\n* Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg\n* Informed consent signed by the patients or his legally accepted representative\n\nExclusion Criteria:\n\n* Under the age of six, at the moment of inclusion\n* Tested negative for HAV and HBV antibodies'}, 'identificationModule': {'nctId': 'NCT00139828', 'briefTitle': 'Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prothya Biosolutions'}, 'officialTitle': 'Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)', 'orgStudyIdInfo': {'id': 'KB2000.03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'The amount of Nonafact® to be administered and the frequency of treatment is based on the SmPC and should always be determined on the basis of the clinical effectiveness in the individual patient', 'interventionNames': ['Drug: human coagulation Factor IX']}], 'interventions': [{'name': 'human coagulation Factor IX', 'type': 'DRUG', 'otherNames': ['Nonafact'], 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'LUMC', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'UMC St. Radboud', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '2545 CH', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Leyenburg Hospital', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '3584CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Van Creveldkliniek', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'E P Mauser-Bunschoten, MD, PdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prothya Biosolutions', 'class': 'INDUSTRY'}}}}