Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
Recruiting now · Phase 2
Conditions studied: Immune Thrombocytopenia, Treatment
In brief
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.
Key facts
- Study ID
- NCT06281327
- Run by
- Institute of Hematology & Blood Diseases Hospital, China
- People needed
- 60
- Starts
- 2024-03-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-02-24
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Tianjin, China (enrolling)
Full record on ClinicalTrials.gov
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