Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-31 @ 6:13 PM
Study NCT ID:
NCT02263456
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2014-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B
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', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-07'}, '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': '2001-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration/time curve (AUC) for plasma Factor IX', 'timeFrame': 'Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose'}]}, 'conditionsModule': {'conditions': ['Haemophilia B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bpl.co.uk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n* to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.\n* to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches.\n* to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 12 years or over\n* At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02263456', 'briefTitle': 'A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B', 'organization': {'class': 'OTHER', 'fullName': 'Bio Products Laboratory'}, 'officialTitle': 'An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.', 'orgStudyIdInfo': {'id': 'RP9VFPK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Current Factor IX', 'interventionNames': ['Biological: Replenine®-VF (High Purity Factor IX)']}, {'type': 'EXPERIMENTAL', 'label': 'Replenine®-VF', 'interventionNames': ['Biological: Replenine®-VF (High Purity Factor IX)']}], 'interventions': [{'name': 'Replenine®-VF (High Purity Factor IX)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Current Factor IX', 'Replenine®-VF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hampstead', 'state': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Free Hospital, Pond Street', 'geoPoint': {'lat': 51.55744, 'lon': -0.18213}}, {'city': 'Basingstoke', 'country': 'United Kingdom', 'facility': 'The North Hampshire Hospital, Aldermaston Road', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital, Hills Road", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales, Health Park', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Kingston General Hospital, Beverly Road', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary, Infirmary Square', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Lincoln', 'country': 'United Kingdom', 'facility': 'Lincoln County Hospital, Greetwell Road', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bio Products Laboratory', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}