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Study on the effectiveness and safety of Hetrombopag in promoting platelet reconstruction after umbilical cord blood transplantation in children or adolescents

Study on the effectiveness and safety of Hetrombopag in promoting platelet reconstruction after umbilical cord blood transplantation in children or adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099907
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia after umbilical cord blood transplantation

Interventions

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.Age<18 years old, both male and female; 2.Children with hematological disorders who have completed their first umbilical cord blood transplantation; 3.ECOG score <=2 points; 4.The subjects and their legal guardians agree to participate and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Patients who have not engrafted neutrophils within 14 days after transplantation; 2.Patients who develop severe acute GVHD (Graft-Versus-Host Disease) within 14 days after transplantation and have not been controlled; 3.Engraftment Syndrome (ES) that occurs within 14 days after transplantation and is not controlled; 4.Uncontrollable organ damage; 5.Patients with a history of venous/arterial thromboembolism and hereditary coagulation disorders; 6.Patients with abnormal liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) exceeded 3 times the upper limit of normal value, total bilirubin exceeded 3 times the upper limit of normal value, and blood creatinine exceeded 3 times the upper limit of normal value during screening; 7.Patients with QT interval prolongation on electrocardiogram; 8.Other conditions deemed unsuitable for inclusion in the study by the investigator;

Design outcomes

Primary

MeasureTime frame
The time of platelet implantation after transplantation;

Secondary

MeasureTime frame
The time for neutrophils to reach 1.0×109/L after transplantation;Serum ferritin levels;Cumulative incidence of graft-versus-host disease one year after transplantation;The proportion of graft-versus-host disease without recurrence at 1 year;The platelet count reached 50×109/L after transplantation;Incidence of delayed platelet implantation (DPE) (platelet count < 20×109/L 40 days after transplantation);Number of platelet transfusions;Medical expenses during hematopoietic reconstruction;Security;

Countries

China

Contacts

Public ContactShaoyan Hu

Children's Hospital of Soochow University

Hsy139@126.com+86 512 80692929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026