Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jan 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called avatrombopag to see how well it works and how safe it is for patients who have low platelet counts (a condition known as thrombocytopenia) after receiving a type of stem cell transplant called haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Platelets are important for blood clotting, and low levels can lead to serious health issues. The trial is currently looking for participants aged 18 to 65 who either have platelet counts below 20 or need blood transfusions after their transplant.

If eligible and you decide to participate, you'll receive either avatrombopag or a placebo (a treatment with no active ingredients) in a double-blind format, meaning neither you nor the researchers will know which treatment you are receiving. This helps ensure the results are unbiased. Participants will be monitored for the effectiveness of the drug and any potential side effects. Please note that some individuals may not qualify, particularly those with active infections, certain liver issues, or a history of serious heart problems. Your participation will contribute to important research on improving care for patients facing complications after their stem cell transplants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, aged between 18-65 years;
• • 2. PLT\<20×10\^9/L or transfusion dependent on +D7 after haplo-HSCT;
• • 3. Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.
• Exclusion Criteria:
• • 1. With active infection;
• • 2. ALT or AST\>3ULN, or total Bil\>2ULN
• • 3. Ccr\<50 mL/min;
• • 4. With the history of arteriovenous thrombosis;
• • 5. 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;
• • 6. With treatment of drugs to promote platelet production two weekes before enrollment, including but not limited to rhTPO and TPO-RA;
• • 7. HBsAg or anti-HCV or anti-HIV positive;
• • 8. Known to be allergic to avatrombopag and any of its excipients;
• • 9. With secondary or multiple HSCT;
• • 10. 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;
• • 11. With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
• • 12. Deemed unsuitable for enrollment by the investigator for any history of or concomitant medical condition.
• • 13. 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.