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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.
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.
the 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine | Experimental | 2.5-5mg/kg of cyclosporine daily for 3 months |
|
| Rituximab | Active Comparator | 375 mg/ m2 weekly dose for a maximum of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | 2.5-5 mg orally for 3 months |
| |
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| rate of adverse events | according to Common Terminology Criteria for Adverse Events Version 5 | 3months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ghada Abdallah | Contact | +201008138002 | ghadaelsayed2008@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital | Active, not recruiting | Asyut | Asyut Governorate | 17111 | Egypt | |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Drug |
375 mg/ m2 weekly dose for a maximum of 4 weeks |
|
| Assiut university hospital |
| Recruiting |
| Asyut |
| Asyut Governorate |
| Egypt |
|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |