Avatrombopag to Promote Platelet Engraftment After Allo-HSCT
NCT ID: NCT05143892
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2021-12-01
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Avatrombopag
In the 4-weeks'study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20\*10\^9/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food.
Avatrombopag
Avatrombopag administered at the described frequency to achieve a target platelet count
Supportive care
Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin.
Supportive care
Supportive care other than TPO-RAs or recombinant human thrombopoietin.
Interventions
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Avatrombopag
Avatrombopag administered at the described frequency to achieve a target platelet count
Supportive care
Supportive care other than TPO-RAs or recombinant human thrombopoietin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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HAN Yue
Director of hematology department
Principal Investigators
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Yue Han
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The first affiliated hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Meng Zhou, MD
Role: primary
References
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Zhou M, Qi J, Gu C, Wang H, Zhang Z, Wu D, Han Y. Avatrombopag for the treatment of thrombocytopenia post hematopoietic stem-cell transplantation. Ther Adv Hematol. 2022 Sep 28;13:20406207221127532. doi: 10.1177/20406207221127532. eCollection 2022.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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SOOCHOW-HY-2021-11
Identifier Type: -
Identifier Source: org_study_id