Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called avatrombopag to see how safe and effective it is for treating children and teenagers with a condition known as primary immune thrombocytopenia (ITP). ITP is a disease that causes low platelet counts in the blood, which can lead to easy bruising or bleeding. This trial is specifically for patients aged 6 to 18 years old who have previously tried another medication called eltrombopag but found it didn’t work well for them or caused unwanted side effects.

If your child is eligible to participate, they will be closely monitored during the study to ensure their safety and to see how well avatrombopag helps improve their platelet counts. Participants will need to understand the study procedures and agree to take part by signing a consent form. This trial is currently recruiting participants, and it provides a chance to contribute to research that could help improve treatment options for ITP in children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 6-18 years old (including both ends), male and female;
• • Diagnosed with primary immune thrombocytopenia (ITP);
• • Patients who had previously received eltrombopag treatment and then converted to avatrombopag treatment because of ineffectiveness (platelet count \< 30×10\^9/L after eltrombopag treatment, or platelet count increased less than 2 times of the basic value, or bleeding) or large platelet fluctuation or due to patient preference, economic reasons and other reasons;
• • Cardiac function of the New York Society of Cardiac Function ≤ 2;
• • Understand the study procedure and voluntarily sign the informed consent.
• Exclusion Criteria:
• • Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.;
• • Subjects with primary disease of important organs (liver, kidney, heart, etc.), or with immune system diseases;
• • Subjects who are known to be allergic to avatrombopag or any of its excipients;
• • Subjects who had used rituximab within the last 3 months;
• • Subjects who underwent splenectomy within the last 3 months；
• • Subjects with a history of abnormal platelet aggregation that may affect the reliability of platelet count measurements；
• • Any medical history or condition that the investigator deems unsuitable for participation in the study.