Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-11 @ 6:36 PM
Study NCT ID:
NCT02263469
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Factor IX Administered per Month (IU/KG)', 'timeFrame': '26 Weeks'}]}, 'conditionsModule': {'conditions': ['Haemophilia B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bpl.co.uk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02263469', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years', 'organization': {'class': 'OTHER', 'fullName': 'Bio Products Laboratory'}, 'officialTitle': 'An Open Multi-centre Phase III Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients Under the Age of 6 Years', 'orgStudyIdInfo': {'id': 'R9VF03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Replenine®-VF', 'interventionNames': ['Biological: Replenine®-VF (High Purity Factor IX)']}], 'interventions': [{'name': 'Replenine®-VF (High Purity Factor IX)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Replenine®-VF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '83045', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '79044', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bio Products Laboratory', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}