Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-07 @ 4:44 AM
Study NCT ID:
NCT04106895
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2019-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of treatments given for an ongoing bleeding episodes', 'timeFrame': '6 months', 'description': 'Estimate the proportion of treatments given for an ongoing bleeding episodes (opposed to preventative treatment administered for example before surgery or to regular prophylaxis)'}], 'secondaryOutcomes': [{'measure': 'On-demand Treatment Success', 'timeFrame': '6 months', 'description': 'on-demand treatment of spontaneous or surgical bleeding episodes, success is defined as bleeding control (complete cessation of bleeding or \\< 20% decrease in hemoglobin).'}, {'measure': 'Surgical Prophylaxis Success', 'timeFrame': '6 months', 'description': 'Surgical prophylaxis success is defined as no bleeding or oozing and control of bleeding with fibrinogen concentrate (as anticipated or requiring increased dosing or additional infusions not originally anticipated).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bleeding']}, 'descriptionModule': {'briefSummary': 'To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having received Fibryga® ("on-demand" or for regular prophylaxis) in the centres participating in the study during the recollection period (limited to 7 patients by centre and by period). A total of 4 recollection periods is planned by centre.\n\nData from all consecutive patients having received Fibryga® whatever the indication (congenital or acquired fibrinogen deficiency; "on-demand" or regular prophylaxis) will be collected. The data collection will be limited to 7 patients by centre and by period, meaning that only data from the 7 first patients treated during the recollection period willbe collected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with fibrinogen deficiency (congenital or acquired)\n* Having received an treatment with Fibryga® during the recollection period\n* Having been informed of the potential retrospective collection of their data by a Clinical Research Associate mandated by Octapharma® when Fibryga® has been delivered and who did not refuse.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT04106895', 'briefTitle': 'Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data', 'organization': {'class': 'INDUSTRY', 'fullName': 'Octapharma'}, 'officialTitle': 'Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data', 'orgStudyIdInfo': {'id': 'FORMA-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibryga', 'interventionNames': ['Drug: Fibryga']}], 'interventions': [{'name': 'Fibryga', 'type': 'DRUG', 'description': 'Fibryga', 'armGroupLabels': ['Fibryga']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33404', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux Study Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92350', 'city': 'Le Plessis-Robinson', 'country': 'France', 'facility': 'Le Plessis Robinsin Study Site', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'facility': 'Marseille Study Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes Study Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '26953', 'city': 'Valence', 'country': 'France', 'facility': 'Valence Study Site', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Octapharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}