NCT05823376

Avatrombopag for Platelet Recovery Post-UCBT in Patients With Bone Marrow Failure Disease

Efficacy and Safety of Avatrombopag for Platelet Recovery After Unrelated Cord Blood Transplantation in Patients With Bone Marrow Failure Disease: a Single-center, Single-arm, Phase II Trial

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Avatrombopag for platelet recovery after unrelated cord blood transplantation (UCBT) in patients with bone marrow failure disease

Detailed description

Persistent thrombocytopenia is a common complication after umbilical cord blood transplantation (UCBT), which necessitates platelet transfusion and leads to increased transplant-related mortality. This is a single-center, single-arm, phase II clinical trial aimed at evaluating the efficacy and safety of Avatrombopag for platelet recovery after UCBT in patients with bone marrow failure disease (BMFD). The study was conducted in patients diagnosed with BFMD and receiving UCBT. After the subjects signed and informed and qualified, they received Avatrombopag treatment from the first day to the 28th day after transplantation. In this study, the cumulative of platelet implantation rate at 28 days after transplantation was used as the main therapeutic index, and 40 patients were planned to be enrolled.

Conditions

• Platelet Recovery After Umbilical Cord Blood Transplantation

Interventions

Type	Name	Description
DRUG	Avatrombopag	Indications for drug reduction and withdrawal: excluding blood transfusion factors, the reduction will be 20mg/d when PLT≥50×10\^9/L; Drug administration will be stopped when PLT≥100×10\^9/L.

Timeline

• Start date: 2023-05-04
• Primary completion: 2025-01-31
• Completion: 2025-02-28
• First posted: 2023-04-21
• Last updated: 2024-12-31

Locations

1 site across 1 country: China