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

November 26, 2025 updated by: Jun Yang, Beijing Children's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Drug: Hetrombopag
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accumulated platelet engraftment rate
Time Frame: From enrollment to 60 days post-transplant
Platelet engraftment is defined as a continuous 7-day PLT ≥ 20 × 10^9/L without platelet infusion.
From enrollment to 60 days post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of platelet transfusions
Time Frame: From enrollment to 60 days post-transplant
From enrollment to 60 days post-transplant
Time to platelet engraftment
Time Frame: From enrollment to 60 days post-transplant
From enrollment to 60 days post-transplant
progression-free survival (PFS)
Time Frame: From enrollment to 60 days post-transplant
The time from enrollment to the first occurrence of disease progression or death from any cause
From enrollment to 60 days post-transplant
Adverse events
Time Frame: From medication to 30 days after discontinuation
Any adverse events within 30 days of discontinuation
From medication to 30 days after discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

February 8, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2024]-Y-002-D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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