Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
1 other identifier
interventional
30
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2021
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedStudy Start
First participant enrolled
October 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
March 20, 2025
March 1, 2025
5 years
September 16, 2021
March 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
the proportion of complete response
Hb ≥12 g/dL and normalization of all hemolytic markers
3months
the proportion of partial response
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
3months
Secondary Outcomes (1)
rate of adverse events
3months
Study Arms (2)
Cyclosporine
EXPERIMENTAL2.5-5mg/kg of cyclosporine daily for 3 months
Rituximab
ACTIVE COMPARATOR375 mg/ m2 weekly dose for a maximum of 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.
You may not qualify if:
- any contraindications to the drugs of the study.
- any identified secondary cause of the AIHA.
- pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Assiut university hospital
Asyut, Asyut Governorate, 17111, Egypt
Assiut university hospital
Asyut, Asyut Governorate, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer in internal medicine department of faculty of medicine,Assiut university
Study Record Dates
First Submitted
September 16, 2021
First Posted
September 27, 2021
Study Start
October 20, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share