A Prospective Study on the Treatment of Recurrent/Refractory/Intolerable NSAA With Lusutrombopag

Aplastic Anemia Clinical Trial

Official title: An Exploratory Study on the Efficacy and Safety of Lusutrombopag in the Treatment of Recurrent/Refractory/Intolerable NSAA

Status Not yet recruiting

Clinical Trial Summary

In a prospective, single-arm study, the efficacy and safety of Lusutrombopag in the treatment of relapsed/refractory/intolerable non-severe aplastic anemia (NSAA) were explored.

Clinical Trial Description

The enrolled patients: were given Lusutrombopag at 3mg/qd orally for 12 weeks (the starting dose of lusutrombopag was 3mg, taken once daily. After 2 weeks of continuous administration, the dose was increased by 3mg every 2 weeks based on the platelet count and safety of the subjects. The dose was gradually increased to 9mg/d over a total of 12 weeks). The treatment duration was at least 3 months. When the platelet increase was <20×10^9/L, the daily dose was increased by 3mg, up to a maximum of 9mg/day. When the platelet increase was ≥50×109/L and ≤200×10^9/L, the dose was maintained at the previous level. When the platelet count was ≥200×10^9/L and ≤400×10^9/L, the daily dose was reduced by 3mg. When the platelet count was >400×10^9/L, the drug could be suspended, and the dose was reduced by 3mg when the platelet count decreased to <200×10^9/L. In this case, if the lowest dose of 3mg/day was used, the drug could be suspended. Responders continued treatment for 6 months. Other TPO-RA therapies were not allowed during the study period. ;

Related Conditions & MeSH terms

• Anemia, Aplastic
• Aplastic Anemia

• NCT number: NCT06426043
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Contact: Bing Bing, PhD
• Phone: 13601059938
• Email: Hanbing_li@sina.com.cn
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Completion date: August 2025