Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-18
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Avatrombopag
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Henan Cancer Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
Tianjin Children's Hospital
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Source ClinicalTrials.gov