Orelabrutinib in the Treatment of Relapsed/Refractory AIHA

1. wAIHA Treatment Regimen: Group A (50mg group): Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \< 20 g/L, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks. Group B (100mg group): Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety. 2. cAIHA Treatment Regimen: Group C (150mg group): Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.

NCT Number	NCT07453368
Lead Sponsor	Peking Union Medical College Hospital
Conditions	Autoimmune Hemolytic Anemia (AIHA)
Enrollment	50 participants
Start Date	2026-03-01
Primary Completion	2027-03-01 (estimated)
Study Completion	2028-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-16