NCT06281327 Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
| NCT ID | NCT06281327 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-12 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
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, hear