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Hetrombopag for the Enhancement of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation

NCT05727917 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-02-14

No results posted yet for this study

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.

Conditions

  • Hematological Disease
  • Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Hetrombopag

After hematopoietic stem cell reinfusion, the patients begin to take hetrombopag orally 7.5mg/d, until the patients reach complete platelet response.The treatment will stop when patients accept 21 consecutive days of treatment or reach the discontinuation criteria.

OTHER

placebo

After hematopoietic stem cell transfusion, the patients will be only observed, and the observation during the treatment period will be ended after 30 days

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Erlie Jiang · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-05-31
Completion
2024-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727917 on ClinicalTrials.gov