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Study identifier: NCT07453368 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Orelabrutinib in the Treatment of Relapsed/Refractory AIHA

Condition: Autoimmune Hemolytic Anemia (AIHA)  ·  Sponsor: Peking Union Medical College Hospital

PhasePhase 2
Planned participants50
Who can joinAll sexes, 18 Years to 85 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Miao Chen  ·  +86 18618230229  ·  chenm@pumch.cn

Chuanhuan Liu  ·  86+1323861016  ·  LiuCH0310@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Peking Union Medical College HospitalBeijing, Beijing Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07453368