Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT06281327, who can take part
Where in China
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeTianjin, ChinaContact: Lei Zhang, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06281327
- Record updated
- 24 February 2025
- Original description
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.Read full original descriptionShow less
A Prospective, One-arm and Open Clinical Study to Assess Efficacy and Safety of Avatrombopag in the Treatment of Pediatric Primary Immune Thrombocytopenia
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.
Inclusion: 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: 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; Any medical history or condition that the investigator deems unsuitable for participation in the study; Subjects with a history of abnormal platelet aggregation that may affect the reliability of platelet count measurements；; Subjects who had used rituximab within the last 3 months; Subjects who underwent splenectomy within the last 3 months；.