NCT07001397

Study on the Short-term Efficacy and Safety of Recombinant Human Thrombopoietin Combined With Immunosuppressant Sequential Eltrombopag Ethanolamine Dry Suspension in the Treatment of SAA/TD-NSAA

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study included adult patients ≥18 years old with SAA and TD-NSAA who had no HLA-matched sibling donors or were not suitable for first-line allogeneic hematopoietic stem cell transplantation due to age, complications, patient wishes, etc. After admission, they were treated with standard IST combined with rhTPO for at least 28 days. After discharge, the sequential treatment of EPAG-PFOS (with an initial dose of 150mg/d) was continued for 2 months (8 weeks), and the follow-up was conducted until the 6th month (24 weeks). It was compared with the historical cohort previously treated with IST combined with EPAG to explore the short-term efficacy and safety of this treatment regimen.

Conditions

• Aplastic Anemias

Interventions

Type	Name	Description
DRUG	EPAG-pfos	The initial dose of EPAG-pfos is 150mg/d orally. The dose is adjusted according to hematological indicators, with a maximum dose of 150mg/d until hematological remission is achieved

Timeline

• Start date: 2025-06-23
• Primary completion: 2026-03-23
• Completion: 2027-03-23
• First posted: 2025-06-03
• Last updated: 2025-06-03