Clinical Trial

A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia

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Summary
wAIHA or EVANS syndrome: Linpriril 40mg, oral, once daily. The therapeutic effect will be evaluated after 4 weeks. If the therapeutic effect does not reach the PR, the dose will be increased to 60mg once a day. After continuing to take it for 4 weeks, the therapeutic effect will be evaluated again. If the PR is not reached, it can be increased to 80mg. If the PR is still not reached after continuing to take it for 4 weeks, it will be discontinued (for a total of 12 weeks). The initial dose is 40mg, taken orally once a day. If the therapeutic effect reaches PR or above after 4 weeks, continue taking this dose. The evaluation is the same as before every 4 weeks. The research period was 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased. cAIHA: Linpriril 80mg, oral administration, once daily. The therapeutic effect was evaluated every 4 weeks. The research period was 12 weeks. The treatment was discontinued if the therapeutic effect did not reach the PR within 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.
Trial Details
NCT Number NCT07149818
Lead Sponsor Peking Union Medical College Hospital
Conditions Autoimmune Hemolytic Anemia
Enrollment 22 participants
Start Date 2025-09-01
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-02