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NCT Number: NCT06818916

Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT 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.

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Key information

Conditions

Delayed Platelet Engraftment Autologous Hematopoietic Stem Cell Transplantation Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, China

Location status: Recruiting

Location contact

Dr. Yang

CONTACT

[email protected]

86-010-59617614

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hetrombopag

Drug

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.

Primary outcomes

  1. 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.

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)

    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

  4. Adverse events

    Time frame: From medication to 30 days after discontinuation

    Any adverse events within 30 days of discontinuation

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Yang

CONTACT

[email protected]

86-010-59617614

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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