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

NCT ID: NCT06818916

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2027-07-31

Brief 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.

Conditions

Delayed Platelet Engraftment; Neuroblastoma; Autologous Hematopoietic Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Hetrombopag

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Yang

Beijing Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Dr. Yang

Role: CONTACT

yangjundabby@outlook.com

86-010-59617614

Facility Contacts

Dr. Yang

Role: primary

yangjundabby@outlook.com

86-010-59617614

Other Identifiers

[2024]-Y-002-D

Identifier Type: -

Identifier Source: org_study_id