Hetrombopag for improving platelet recovery in children with neuroblastoma after stem cell transplant
Efficacy and Safety of Hetrombopag in Promoting Platelet Engraftment After Autologous Hematopoietic Stem Cell Transplantation in Children With Neuroblastoma
This study is testing if a new medication called hetrombopag can help children with neuroblastoma recover their platelet levels faster after a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Beijing Children's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06818916 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hetrombopag in promoting platelet engraftment in children diagnosed with neuroblastoma who are undergoing autologous hematopoietic stem cell transplantation. Participants will receive hetrombopag daily for six weeks or until their platelet count exceeds 100 x 10^9/L. The primary objective is to determine whether this medication can enhance the recovery of platelet levels post-transplantation, which is crucial for preventing complications related to low platelet counts.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old diagnosed with neuroblastoma who are receiving their first autologous hematopoietic stem cell transplantation.
Not a fit: Patients with severe liver dysfunction, recent cardiovascular events, or thromboembolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve platelet recovery and reduce complications in pediatric patients undergoing stem cell transplantation for neuroblastoma.
How similar studies have performed: While the specific use of hetrombopag in this context may be novel, similar studies have shown promise in using other agents to enhance platelet engraftment in hematopoietic stem cell transplantation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Dr. Yang
- Email: yangjundabby@outlook.com
- Phone: 86-010-59617614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.