Efficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-31

Summary

This is a randomized, open-label, phase II study to compare the efficacy of eltrombopag combined with tacrolimus//Cyclosporin A to eltrombopag alone in Chinese subjects with refractory or relapsed aplastic anemia. The safety would also be evaluated. Patients would be randomized to receive eltrombopag alone or eltrombopag combined with tacrolimus//Cyclosporin A. Treatment with eltrombopag will be started at 25 mg/day and increased by 25 mg/day every 2 weeks according to the platelet count up to 150 mg/day. Tacrolimus will be given at 1mg bid with the target concentration to be 5-10 ng/ml throughout the study. Cyclosporin A will be give at the target comcentration to be 100-150ng/ml. The hematological response rate and safety will be recorded and compared at 3, 6 months and 1 year after starting the study treatment (Week 13, 26 and 52).

• Phase: Phase 2

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Cyclosporine; Cyclosporins; Tacrolimus