Last updated: December 21, 2022
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting
Phase
2
Condition
Thrombocytopenic
Treatment
N/AClinical Study ID
NCT05143892
SOOCHOW-HY-2021-11
Ages 18-60 All Genders
Study Summary
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
Connect with a study center
The first affiliated hospital of Soochow University
Suzhou, Jiangsu 215000
ChinaActive - Recruiting
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