Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-29 @ 3:49 AM
Study NCT ID:
NCT05057468
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of complete response', 'timeFrame': '3months', 'description': 'Hb ≥12 g/dL and normalization of all hemolytic markers'}, {'measure': 'the proportion of partial response', 'timeFrame': '3months', 'description': '(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement'}], 'secondaryOutcomes': [{'measure': 'rate of adverse events', 'timeFrame': '3months', 'description': 'according to Common Terminology Criteria for Adverse Events Version 5'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Autoimmune Hemolytic Anemia']}, 'descriptionModule': {'briefSummary': 'the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This study compares cyclosporin versus rituximab in steroid-refractory anemia.', 'detailedDescription': 'Auto-immune hemolytic anemia (AIHA) is a heterogeneous syndrome in adults. This disease is associated with significant morbidity-mortality. First-line treatment with prolonged corticosteroid is well identified but there is not enough data about cyclosporine treatment in case of resistance or dependence on steroids.\n\nthe cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This drug is cheap, licensed in immunologic diseases, and does not expose to major infections. So, we compare cyclosporin versus rituximab in steroid-refractory anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged more than 18 years old from any sex with a diagnosis of primary warm autoimmune hemolytic anemia (AIHA) based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test who have disease progression or failure after treatment with steroid therapy, or who are intolerant to treatment, or who refuse standard treatment.\n* No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.\n\nExclusion Criteria:\n\n* any contraindications to the drugs of the study.\n* any identified secondary cause of the AIHA.\n* pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT05057468', 'briefTitle': 'Second-line Treatment of Primary Autoimmune Hemolytic Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia', 'orgStudyIdInfo': {'id': '17300534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclosporine', 'description': '2.5-5mg/kg of cyclosporine daily for 3 months', 'interventionNames': ['Drug: Cyclosporine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab', 'description': '375 mg/ m2 weekly dose for a maximum of 4 weeks.', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Cyclosporine', 'type': 'DRUG', 'description': '2.5-5 mg orally for 3 months', 'armGroupLabels': ['Cyclosporine']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': '375 mg/ m2 weekly dose for a maximum of 4 weeks', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17111', 'city': 'Asyut', 'state': 'Asyut Governorate', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Egypt', 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Asyut', 'state': 'Asyut Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mai Kamal, MD', 'role': 'CONTACT', 'email': 'mai_heamatology@aun.edu.eg', 'phone': '+201223971678'}], 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'ghada Abdallah', 'role': 'CONTACT', 'email': 'ghadaelsayed2008@yahoo.com', 'phone': '+201008138002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in internal medicine department of faculty of medicine,Assiut university', 'investigatorFullName': 'Ghada E. M. Abdallah', 'investigatorAffiliation': 'Assiut University'}}}}