RecruitingPhase 3NCT05057468
Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Sponsor
Assiut University
Enrollment
30 participants
Start Date
Oct 20, 2021
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria2
- 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.
Exclusion Criteria3
- any contraindications to the drugs of the study.
- any identified secondary cause of the AIHA.
- pregnant or lactating women.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGCyclosporine
2.5-5 mg orally for 3 months
DRUGRituximab
375 mg/ m2 weekly dose for a maximum of 4 weeks
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05057468