Status:
RECRUITING
Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Xiangya Hospital of Central South University
Sichuan Provincial People's Hospital
Conditions:
Thrombocytopenia
Stem Cell Transplant Complications
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, ...
Detailed Description
Thrombocytopenia is a common and severe complication after haplo-HSCT, including primary isolated thrombocytopenia (PIT) and secondary failure of platelet recovery (SFPR), which may cause bleeding and...
Eligibility Criteria
Inclusion
- Male or female, aged between 18-65 years;
- PLT\<20×10\^9/L or transfusion dependent on +D7 after haplo-HSCT;
- Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.
Exclusion
- With active infection;
- ALT or AST\>3ULN, or total Bil\>2ULN
- Ccr\<50 mL/min;
- With the history of arteriovenous thrombosis;
- With history of cardiovascular disease (such as NYHA Class III/IV congestive heart failure, arrhythmia that increases the risk of thromboembolic events \[such as atrial fibrillation\] and angina), and subjects who have undergone coronary stent implantation, angioplasty, or coronary artery bypass grafting;
- With treatment of drugs to promote platelet production two weekes before enrollment, including but not limited to rhTPO and TPO-RA;
- HBsAg or anti-HCV or anti-HIV positive;
- Known to be allergic to avatrombopag and any of its excipients;
- With secondary or multiple HSCT;
- Females who were pregnant or breastfeeding or who had fertile ability but refuse to take effective contraceptive measures during and one month after this trial;
- With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
- Deemed unsuitable for enrollment by the investigator for any history of or concomitant medical condition.
- Concomitant medication:The rhIL-11, rhTPO or TPO-RA(such as eltrombopag, hetrombopag and romiplostim) and desitabine, etc. were not allowed for use during this trial.
Key Trial Info
Start Date :
May 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06202625
Start Date
May 13 2024
End Date
October 30 2025
Last Update
October 1 2024
Active Locations (14)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Guangzhou First People's Hospital, School of Medicine, South China University of Technology
Guangzhou, Guangdong, China
3
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
4
The First Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang, China