Delayed Platelet EngraftmentNCT06818916
Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT in Children With Neuroblastoma
A study testing Hetrombopag in people with Delayed Platelet Engraftment and Neuroblastoma, run by Beijing Children's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Delayed Platelet Engraftment, Neuroblastoma, Autologous Hematopoietic Stem Cell Transplantation
- What is being tested?
- Hetrombopag
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical University
Beijing
Dr. Yang, 86-010-59617614, yangjundabby@outlook.com
About this study
Official title: 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.
- Conditions
- Delayed Platelet Engraftment, Neuroblastoma, Autologous Hematopoietic Stem Cell Transplantation
- Being tested
- Hetrombopag
- Keywords
- Hetrombopag, delayed platelet engraftment, neuroblastoma, pediatrics, autologous hematopoietic stem cell transplantation
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HetrombopagDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Hetrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated platelet engraftment rate
Platelet engraftment is defined as a continuous 7-day PLT ≥ 20 × 10^9/L without platelet infusion.
Measured: From enrollment to 60 days post-transplant
Secondary outcomes (4)
Number of platelet transfusions
Measured: From enrollment to 60 days post-transplant
Time to platelet engraftment
Measured: From enrollment to 60 days post-transplant
progression-free survival (PFS)
The time from enrollment to the first occurrence of disease progression or death from any cause
Measured: From enrollment to 60 days post-transplant
Adverse events
Any adverse events within 30 days of discontinuation
Measured: From medication to 30 days after discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start30 Jun 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Platelet EngraftmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Yang, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818916
- Sponsor's protocol ID
- [2024]-Y-002-D
- Status last verified
- Nov 2025
- First submitted
- 20 Jun 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hetrombopag in Promoting Platelet Engraftment After Autologous Hematopoietic Stem Cell Transplantation in Children With Neuroblastoma
- ClinicalTrials.gov ID
- NCT06818916
- Acronym / sponsor ID
- [2024]-Y-002-D
- Conditions
- Delayed Platelet Engraftment, Neuroblastoma, Autologous Hematopoietic Stem Cell Transplantation
- Keywords
- Hetrombopag, delayed platelet engraftment, neuroblastoma, pediatrics, autologous hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Hetrombopag |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HetrombopagPatients 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. | Drug | Experimental group |
Primary outcome
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.
4 secondary outcomes
Number of platelet transfusions
Time frame: From enrollment to 60 days post-transplant
Time to platelet engraftment
Time frame: From enrollment to 60 days post-transplant
progression-free survival (PFS)
Time frame: From enrollment to 60 days post-transplant
Adverse events
Time frame: From medication to 30 days after discontinuation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Related trials for Delayed Platelet Engraftment
RecruitingPhase 2
Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
MDS (Myelodysplastic Syndrome), Aplastic Anemia (AA)
RecruitingPhase 1
Romiplostim N01 for Platelet Recovery After Haploidentical HSCT
Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hetrombopag in people with Delayed Platelet Engraftment and Neuroblastoma, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Yang (86-010-59617614, yangjundabby@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulated platelet engraftment rate (time frame: From enrollment to 60 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.