Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02246868
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
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', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, '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': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incremental Recovery', 'timeFrame': 'Comparison of Baseline with 3 months post-baseline'}]}, 'conditionsModule': {'conditions': ['Haemophilia A']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bpl.co.uk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02246868', 'briefTitle': 'An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Bio Products Laboratory'}, 'officialTitle': 'An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.', 'orgStudyIdInfo': {'id': '8VWFSE'}}, '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': [{'city': 'Bialystok', 'country': 'Poland', 'facility': 'Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Klinika Haematologii, Akademia Medyczna w Gdansku, u.', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Klinika Haematologii, Akademia Medyczna w Lodzi, ul.', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Klinika Haematologii, Akademia Medyczna w Lublinie, ul.', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Haemophilia Centre, Addenbrooke's Hospital, Hills Road", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': "Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'S10 2JF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Haemophilia Centre, Southampton General Hospital, Tremona Road', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bio Products Laboratory', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}