The Use of Eltrombopag Post HSCT in BMFD
NCT05466201 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2025-12-03
Summary
Bone marrow failure disease(BMFD) is a kind of bone marrow due to congenital or acquired hematopoietic stem cells (hemopoietic stem cell, HSC) function damage. Allogenic hemopoietic stem cell transplantation (Allo-HSCT) might be the most possible treatment to cure the disease.However, 5-26% of patients have been reported to have delayed platelet engraftment (DPE), which is defined as persistent severe thrombocytopenia (\<20 × 109/L) for \>35 days after transplantation . To date, no standard treatment and prevention has been recommended for DPE. In patients with DPE, the amount of transfusion, the increased risk of infection, and the prolonged average hospital stay were independent risk factors affecting the prognosis of allo-HSCT patients. Due to continuous and progressive failure in the bone marrow hematopoiesis, thrombocytopenia post HSCT is more common in BMFD patients and often achieves low response to conventional therapy, such as platelet transfusion. Therefore, it is of great significance to effectively promote hematopoietic reconstruction to improve the prognosis of transplant patients.
Conditions
- Stem Cell Transplant Complications
Interventions
- DRUG
-
Eltrombopag 25 MG Oral Tablet
Since thrombopoietin receptor agonists (TPO-RAs) have never been regularly used for promotion of cell engraftment post hematopoietic stem cell transplantation HSCT), we design this eltrombopag intervention to evaluate the safety and efficacy of TPO-RAs post HSCT.
- DRUG
-
Supportive care
Patients receive transfusion of blood products, including platelets and red blood cells.
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
Depei Wu, PhD,MD · The First Affiliated Hospital of Soochow University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-22
- Primary Completion
- 2025-07-31
- Completion
- 2025-10-31
Countries
- China
Study Locations
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