RecruitingNot ApplicableNCT06818916

Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT in Children With Neuroblastoma

Efficacy and Safety of Hetrombopag in Promoting Platelet Engraftment After Autologous Hematopoietic Stem Cell Transplantation in Children With Neuroblastoma


Sponsor

Beijing Children's Hospital

Enrollment

30 participants

Start Date

Jun 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if hetrombopag promotes platelet engraftment in neuroblastoma children undergoing autologous hematopoietic stem cell transplantation. The main question it aims to answer is: · Does drug hetrombopag promote platelet engraftment? Participants will take hetrombopag every day for 6 weeks or until platelet \> 100\*10\^9/L.


Eligibility

Max Age: 18 Years

Inclusion Criteria5

  • Age\<18 years old;
  • Diagnosed as neuroblastoma;
  • ECOG ≤ 2;
  • First time receiving autologous hematopoietic stem cell transplantation;
  • The subjects or their legal guardians agree to participate and sign the informed consent form.

Exclusion Criteria4

  • ALT/AST \> 3 ULN, or TBIL \> 1.5 ULN;
  • Have experienced congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication treatment within one year prior to enrollment, or have experienced myocardial infarction or cerebral infarction within three months prior to enrollment;
  • Suffering from thromboembolic diseases;
  • Other situations that are not suitable for inclusion in the study determined by researchers.

Interventions

DRUGHetrombopag

Patients enrolled were administered Hetrombopag starting from +4d after transplantation on routine medication of recombinant human thrombopoietin injection (rhTPO). The starting dose of Hetrombopag is 2.5mg or 5mg, oral, once daily (starting at 5mg/d for body weight\>20kg; starting from 2.5mg/d for body weight ≤ 20kg). Adjust the dosage based on platelet count every two weeks, with a maximum dose of 7.5mg per day. Stop the medication after 6 weeks of continuous use or when PLT reaches 100 × 10\^9/L.


Locations(1)

Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical University

Beijing, China

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NCT06818916


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