NCT05057468 Second-line Treatment of Primary Autoimmune Hemolytic Anemia
| NCT ID | NCT05057468 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assiut University |
| Condition | Primary Autoimmune Hemolytic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-10-20 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 30 participants in total. It began in 2021-10-20 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * any contraindications to the drugs of the study. * any identified secondary cause of the AIHA. * pregnant or lactating women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05057468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Autoimmune Hemolytic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05057468 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 30 participants.
Is NCT05057468 currently recruiting?
Yes, NCT05057468 is actively recruiting participants. Contact the research team at ghadaelsayed2008@yahoo.com for enrollment information.
Where is the NCT05057468 trial being conducted?
This trial is being conducted at Asyut, Egypt, Asyut, Egypt.
Who is sponsoring the NCT05057468 clinical trial?
NCT05057468 is sponsored by Assiut University. The trial plans to enroll 30 participants.