Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Sponsor
Assiut University
Study ID
NCT05057468
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Primary Autoimmune Hemolytic Anemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclosporine — DRUG
    2.5-5 mg orally for 3 months
  • Rituximab — DRUG
    375 mg/ m2 weekly dose for a maximum of 4 weeks

Study Details

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.

Key Dates

Start date
Oct 20, 2021
Status verified
Mar 2025
Primary completion
Nov 1, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cyclosporine
    2.5-5mg/kg of cyclosporine daily for 3 months
  • Active Comparator: Rituximab
    375 mg/ m2 weekly dose for a maximum of 4 weeks.

Primary Outcome Measure

the proportion of complete response [ Time Frame: 3months ]

Central Contacts