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

Not Applicable

Recruiting

• Conditions: Delayed Platelet Engraftment; Neuroblastoma; Autologous Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Hetrombopag

• Registration Number: NCT06818916
• Lead Sponsor: Beijing Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-20
• Study Start: 2024-06-30
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2027-04-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Hetrombopag	-

Primary Outcome Measures

Name	Time	Method
Accumulated platelet engraftment rate	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical University; 🇨🇳 Beijing, China