Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-06 @ 1:48 AM
Study NCT ID:
NCT02246894
Status:
COMPLETED
Last Update Posted:
2018-02-15
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 Optivate® in Children Under 6 Years of Age With Haemophilia A.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568131', 'term': 'optivate'}, {'id': 'D005169', 'term': 'Factor VIII'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption of FVIII', 'timeFrame': 'Day 0 to Week 26'}]}, 'conditionsModule': {'conditions': ['Haemophilia A']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bpl.co.uk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objectives of this study are:\n\n* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).\n* to assess clinical outcome when treating a bleed with Optivate®.\n* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .\n* to assess FVIII inhibitor development during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.\n\nChildren with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02246894', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.', 'organization': {'class': 'OTHER', 'fullName': 'Bio Products Laboratory'}, 'officialTitle': 'An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.', 'orgStudyIdInfo': {'id': '8VWF05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optivate®', 'description': 'Optivate® (Human Coagulation Factor VIII)', 'interventionNames': ['Biological: Optivate® (Human Coagulation Factor VIII)']}], 'interventions': [{'name': 'Optivate® (Human Coagulation Factor VIII)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Optivate®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-093', 'city': 'W. Chodzki Str.', 'state': 'Lublin Voivodeship', 'country': 'Poland', 'facility': "Children's Haematology and Oncology Clinic, Ul."}, {'zip': '30-663', 'city': 'Krakow', 'country': 'Poland', 'facility': "Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.", 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '61-825', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '00-576', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-345', 'city': 'Wroclaw', 'country': 'Poland', 'facility': "Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.", 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bio Products Laboratory', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}