Hetrombopag for the Enhancement of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
Status:
Recruiting
Trial end date:
2024-10-31
Target enrollment:
Participant gender:
Summary
This investigator-initiated, prospective, multicenter, open-label, randomized, controlled
clinical study is designed to evaluate the clinical efficacy and safety of hetrombopag for
promoting platelet engraftment after allo-HSCT in patients with hematological disease.
After signing the informed consent form, the patients will enter the screening period (up to
14 days), and the qualified patients will be randomly selected into the experimental group
and the control group according to the ratio of 1:1.
Experimental group: After hematopoietic stem cell reinfusion, the patients begin to take
hetrombopag orally 7.5mg/d, until the patients reach complete platelet response (CR, platelet
count ≥ 50×109/L for 3 consecutive days without platelet transfusions for 7 consecutive
days). The treatment will stop when patients accept 21 consecutive days of treatment or reach
the discontinuation criteria.
Control group: After hematopoietic stem cell transfusion, the patients will be only observed,
and the observation during the treatment period will be ended after 30 days.
Patients will continue to enter the follow-up period (+ 100 days after transplantation) and
the survival follow-up period (1 year after transplantation) after the end of the treatment
period.