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ENROLLING BY INVITATION
NCT07003269

Observational Study: Hetrombopag for Platelet Recovery in Haploidentical HSCT

Sponsor: Haikou Affiliated Hospital of Central South University Xiangya School of Medicine

View on ClinicalTrials.gov

Summary

The objective of this observational study is to investigate the long-term effects of Hetrombopag in promoting platelet engraftment during haploidentical hematopoietic stem cell transplantation (HSCT) in children with thalassemia, with a specific focus on a 28-day time window post-transplantation. The core question to be addressed is: Is Hetrombopag safe and effective for platelet engraftment in children with thalassemia undergoing haploidentical HSCT within a 28-day post-transplant period? Subjects who received Hetrombopag as part of routine care for haploidentical HSCT in children with thalassemia will be required to complete a 28-day online survey on platelet engraftment outcomes.

Official title: An Observational Study on the Promotion of Platelet Recovery by Hetrombopag During Haploidentical Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2024-09-01

Completion Date

2026-04-30

Last Updated

2025-06-04

Healthy Volunteers

No

Interventions

DRUG

Hetrombopag

In allogeneic hematopoietic stem cell transplantation, hetrombopag is initiated at 3 µg/kg subcutaneously on day +6 post-transplant. The dose is increased by 2 µg/kg weekly up to a maximum of 10 µg/kg. Treatment is discontinued when platelet counts rise to 100×10⁹/L. If platelet counts remain ≤20×10⁹/L on day +20, hetrombopag is combined with eltrombopag 25 mg orally once daily. Fresh apheresis platelet suspensions (1 therapeutic dose, containing \>2.5×10¹¹ platelets) are administered when platelet counts are ≤20×10⁹/L or when counts are between 21-50×10⁹/L with active bleeding. If engraftment has not occurred by day +28 post-transplant, re-transplantation is required, and hetrombopag is considered ineffective.

Locations (1)

Haikou Affiliated Hospital of Central South University Xiangya School of Medicine

Haikou, Hainan, China