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Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia

RecruitingPhase 2Ages 6 Years - 18 YearsAllInstitute of Hematology & Blood Diseases Hospital…
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In plain words

What the trial is, and whether it could suit you

To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Avatrombopag
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Where

1 site
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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