Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT03951103
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2018-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Arab Emirates']}, 'interventionBrowseModule': {'meshes': [{'id': 'C587014', 'term': 'factor VIII-Fc fusion protein'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2019-05-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ITI with rFVIIIFc: Main dose', 'timeFrame': 'From 2018 to 2022', 'description': 'Main dose will be assessed on the prescribed dose (IU/kg)'}, {'measure': 'ITI with rFVIIIFc: Main injection frequency', 'timeFrame': 'From 2018 to 2022', 'description': 'Main injection frequency will be assessed on the prescribed frequency'}, {'measure': 'ITI with rFVIIIFc: Duration', 'timeFrame': 'From 2018 to 2022', 'description': 'Number of treatment months'}, {'measure': 'ITI with rFVIIIFc: Concomitant by-passing agents', 'timeFrame': 'From 2018 to 2022', 'description': 'Product name and main dose will be used to describe any concomitant use of by-passing agents.'}, {'measure': 'Outcome of ITI with rFVIIIFc: Overall outcome', 'timeFrame': 'From 2018 to 2022', 'description': 'The Investigator will assess overall outcome as: success, partial success, failure, early withdrawal or other.'}, {'measure': 'Outcome of ITI with rFVIIIFc: Time to undetectable inhibitor titer', 'timeFrame': 'From 2018 to 2022', 'description': 'Treatment time to reach undetectable inhibitor levels (\\<0.6 BU/ml)'}, {'measure': 'Outcome of ITI with rFVIIIFc: Time to normal recovery', 'timeFrame': 'From 2018 to 2022', 'description': 'Treatment time to reach normal recovery levels (≥66% of the expected value)'}, {'measure': 'Outcome of ITI with rFVIIIFc: Time to success', 'timeFrame': 'From 2018 to 2022', 'description': 'Treatment time to reach success (see outcome #5)'}, {'measure': 'Outcome of ITI with rFVIIIFc: Inhibitor titer levels', 'timeFrame': 'From 2018 to 2022', 'description': 'BU/ml'}, {'measure': 'Outcome of ITI with rFVIIIFc: Half-life', 'timeFrame': 'From 2018 to 2022', 'description': 'FVIII half-life (hours)'}, {'measure': 'Outcome of ITI with rFVIIIFc: Recovery level', 'timeFrame': 'From 2018 to 2022', 'description': 'FVIII recovery level (%)'}, {'measure': 'Outcome of ITI with rFVIIIFc: Bleeds', 'timeFrame': 'From 2018 to 2022', 'description': 'Number of bleeds per month during ITI-treatment'}, {'measure': 'Long-term outcome after ITI with rFVIIIFc: Occurrence of relapse', 'timeFrame': 'From 2018 to 2022', 'description': 'Occurrence of relapse (Yes/No) will be assessed by the investigator.'}, {'measure': 'Long-term outcome after ITI with rFVIIIFc: Time to relapse', 'timeFrame': 'From 2018 to 2022', 'description': 'Time to occurrence of relapse (see outcome #13)'}, {'measure': 'Long-term outcome after ITI with rFVIIIFc: Treatment regimen', 'timeFrame': 'From 2018 to 2022', 'description': 'Treatment regimen will be described as: ITI, prophylaxis or on-demand; and also by product used.'}, {'measure': 'Long-term outcome after ITI with rFVIIIFc: Bleeds', 'timeFrame': 'From 2018 to 2022', 'description': 'Number of bleeds per month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elocta', 'rFVIIIFc'], 'conditions': ['Hemophilia A With Inhibitor']}, 'referencesModule': {'references': [{'pmid': '40289300', 'type': 'DERIVED', 'citation': 'Klamroth R, Al Saleh M, Glosli H, Schiavulli M, Guillet B, Bystricka L, Schonstein A, Lethagen S. Immune Tolerance Induction With a Recombinant Factor VIII Fc in Haemophilia A: Data From a Chart Review Study. Eur J Haematol. 2025 Aug;115(2):134-141. doi: 10.1111/ejh.14427. Epub 2025 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.', 'detailedDescription': 'A multicenter, international, non- interventional, retrospective and prospective medical chart review study. Data will be collected from medical records for patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI . The study will be descriptive in nature and report on baseline characteristics, treatment and outcomes for patients who have been, or who are currently, treated with rFVIIIFc for ITI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All haemophilia A patients who have been, or who are currently treated with rFVIIIFc for ITI meeting the inclusion and not meeting the exclusion criteria will be invited to participate. Approximately 45 patients from Europe and the Middle East are expected to be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI.\n* Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, before any study-related data collection are undertaken. Assent should be obtained from paediatric patients according to local regulations.\n\nExclusion Criteria:\n\n* Current participation in any investigational medicinal product trial."}, 'identificationModule': {'nctId': 'NCT03951103', 'briefTitle': 'rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Swedish Orphan Biovitrum'}, 'officialTitle': 'A Chart Review Study of Patients With Haemophilia A With Inhibitors Treated With rFVIIIFc (Elocta®) for Immune Tolerance Induction', 'orgStudyIdInfo': {'id': 'Sobi.Elocta-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemophili A patients', 'description': 'Patients treated with rFVIIIFc for ITI', 'interventionNames': ['Other: rFVIIIFc']}], 'interventions': [{'name': 'rFVIIIFc', 'type': 'OTHER', 'otherNames': ['Elocta'], 'description': 'Drug according to prescription', 'armGroupLabels': ['Hemophili A patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Tours', 'country': 'France', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Friedrichshain', 'country': 'Germany', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 52.51559, 'lon': 13.45482}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Mitte', 'country': 'Germany', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 52.52003, 'lon': 13.40489}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '12233', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12713', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Swedish Orphan Biovitrum Research Site (a)', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12713', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Swedish Orphan Biovitrum Research Site (p)', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Swedish Orphan Biovitrum Research Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Stefan Lethagen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Swedish Orphan Biovitrum'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Orphan Biovitrum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}