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RecruitingNCT06818916Updated Dec 3, 2025

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

An interventional study of Hetrombopag in Delayed Platelet Engraftment, Neuroblastoma and Autologous Hematopoietic Stem Cell Transplantation, sponsored by Beijing Children's Hospital. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Beijing Children's Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Delayed Platelet Engraftment
  • Neuroblastoma
  • Autologous Hematopoietic Stem Cell Transplantation

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Keywords

  • Hetrombopag
  • delayed platelet engraftment
  • neuroblastoma
  • pediatrics
  • autologous hematopoietic stem cell transplantation
03

In context

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's planned enrollment of 30 is close to the median of 32 across 475 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Beijing Children's Hospital is the lead sponsor of 51 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Drug: Hetrombopag

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.

06

What researchers measure

Primary outcomes

  1. Accumulated platelet engraftment rate

    Platelet engraftment is defined as a continuous 7-day PLT ≥ 20 × 10\^9/L without platelet infusion.

    Time frame: From enrollment to 60 days post-transplant

Secondary outcomes

  1. Number of platelet transfusions

    Time frame: From enrollment to 60 days post-transplant

  2. Time to platelet engraftment

    Time frame: From enrollment to 60 days post-transplant

  3. progression-free survival (PFS)

    The time from enrollment to the first occurrence of disease progression or death from any cause

    Time frame: From enrollment to 60 days post-transplant

  4. Adverse events

    Any adverse events within 30 days of discontinuation

    Time frame: From medication to 30 days after discontinuation

07

Study locations

1 of 1 sites recruiting
  • Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical University
    Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06818916
Lead sponsor
Beijing Children's Hospital
Responsible party
Jun Yang (Beijing Children's Hospital, Beijing Children's Hospital) — Principal investigator
First posted
Feb 11, 2025
Start date
Jun 30, 2024
Primary completion
Apr 30, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Dec 3, 2025

Study contacts

Dr. Yang
Contact
yangjundabby@outlook.com
86-010-59617614

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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