Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

Last updated: December 21, 2022
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

2

Condition

Thrombocytopenic

Treatment

N/A

Clinical Study ID

NCT05143892
SOOCHOW-HY-2021-11
  • Ages 18-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 theinformed consent form.

Exclusion

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 clinicallysignificant hepatic venous occlusion disease (The disease was defined as the abnormalcondition 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, orsudden drop of blood cell volume ≥10% within 7 days prior to screening;
  • With any other clinical trial of investigational product or device within 30 daysprior to the baseline visit, except for observational study;
  • With treatment of thrombopoietin receptor agonist (TPO-RA) one month beforeenrollment;
  • Deemed unsuitable for enrollment by the investigator.

Study Design

Total Participants: 20
Study Start date:
December 01, 2021
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • The first affiliated hospital of Soochow University

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

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