Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia

Untreated Clinical Trial

Official title: The Efficacy and Safety of Herombopag Combined With Cyclosporine for Patients With Non Severe Aplastic Anemia

Status Recruiting

Clinical Trial Summary

This is a prospective, multicenter, single-arm, phase 2 trial. The aim of this study is to evaluate the efficacy and safety of herombopag combined with cyclosporine for patients with non severe aplastic anemia (NSAA).

Clinical Trial Description

This study aims to improve the 24 weeks response rate. The sample size is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 15 patients. If after 24 weeks at least 9 patients achieved a response, then enrollment was expanded to a total of 43 patients. The null hypothesis was unaccepted if more than 26 of 43 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 54 patients. ;

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Untreated

• NCT number: NCT05660785
• Study type: Interventional
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Lele Zhang, PhD
• Phone: ?15811139278?
• Email: zhanglele@ihcams.ac.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Completion date: May 30, 2025