Study on Avatrombopag for the Promotion of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    20
  • sponsor
    The First Affiliated Hospital of Soochow University
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Updated on 23 October 2022
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Summary

The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.

Description

Patients with thrombocytopenia (PLT<20×10^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment.

Details
Condition Platelet Disorder
Treatment rhTPO, Avatrombopag
Clinical Study IdentifierNCT05143892
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female, aged between 18-60 years
PLT<20×10^9/L after 14 days of allo-HSCT
Expected survival time > 3 months
ECOG performance status 0-2
Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form

Exclusion Criteria

Pregnant or lactating
With severe and uncontrollable infection
With graft-versus-host disease (GVHD) with steroid resistance
With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation
With detected disease recurrence due to chimerism by flow cytometry
With chronic active hepatitis B and C virus infection
With secondary or multiple transplantation, or multiple organ transplantation
With severe heart disease, lung disease, diabetes and metabolic diseases
HIV positive
With a history of PLT dysfunction or bleeding disorders
With the active hepatic venous occlusion disease, or a history of clinically significant hepatic venous occlusion disease (The disease was defined as the abnormal condition of painful hepatomegaly after transplantation with bilirubin ≥ 6.0 mg/dL)
With progressive solid tumor
With severe bleeding requiring transfusion of more than 2 units of red blood cells, or sudden drop of blood cell volume ≥10% within 7 days prior to screening
With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study
With treatment of thrombopoietin receptor agonist (TPO-RA) one month before enrollment
Deemed unsuitable for enrollment by the investigator
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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