Study on Avatrombopag for the Promotion of Platelet Engraftment After Allo-HSCT

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of avatrombopag in the treatment of thrombocytopenia after Allo-HSCT.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University

Criteria

Inclusion Criteria:

• Male or female, aged between 18-60 years;

• PLT has not been reconstructed 14 days after Allo-HSCT (PLT reconstruction was defined as the status of peripheral PLT count > 20*109/L for consecutive 7 days without the need for PLT transfusion);

• 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.