Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Last updated: March 18, 2025
Sponsor: Assiut University
Overall Status: Active - Recruiting

Phase

3

Condition

Anemia

Treatment

Rituximab

Cyclosporine

Clinical Study ID

NCT05057468
17300534
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged more than 18 years old from any sex with a diagnosis of primary warmautoimmune hemolytic anemia (AIHA) based on the presence of hemolytic anemia andserological evidence of anti-erythrocyte antibodies, detectable by the directantiglobulin test who have disease progression or failure after treatment withsteroid therapy, or who are intolerant to treatment, or who refuse standardtreatment.

  • No evidence of a lymphoproliferative malignancy or other autoimmune-relatedunderlying conditions.

Exclusion

Exclusion Criteria:

  • any contraindications to the drugs of the study.

  • any identified secondary cause of the AIHA.

  • pregnant or lactating women.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Rituximab
Phase: 3
Study Start date:
October 20, 2021
Estimated Completion Date:
November 30, 2026

Study Description

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.

Connect with a study center

  • Assiut university hospital

    Assiut,, Assiut 17111
    Egypt

    Site Not Available

  • Assiut university hospital

    Assiut,
    Egypt

    Active - Recruiting

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