Using avatrombopag to treat pediatric immune thrombocytopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of avatrombopag in children aged 6 to 18 years with primary immune thrombocytopenia (ITP) who have previously been treated with eltrombopag. The study focuses on patients who switched to avatrombopag due to poor efficacy, excessive platelet fluctuation, intolerance, or other reasons. Participants will be monitored for their platelet counts and any adverse effects during the treatment period. The goal is to determine if avatrombopag can provide a more effective treatment option for these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Lei Zhang, MD — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Lei Zhang, MD
• Email: zhanglei1@ihcams.ac.cn
• Phone: +86 13502118379

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia

  This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.

  Recruiting Phase 2/3 Chinese SLE Treatment And Research Group · Beijing, Beijing Municipality · NCT07657793

• GL-2045 safety and blood-count help for adults with ITP

  GL-2045 is being tested in adults with immune thrombocytopenia to see if it can safely raise platelet counts like IVIg does.

  Recruiting Phase 1 Gliknik Inc. · Leeds · NCT07605845

• Eltrombopag use in adults with primary ITP: real-world patterns and outcomes

  This study looks at how eltrombopag is used in adult patients with primary ITP and what outcomes are seen in routine care.

  Recruiting Novartis · Basel · NCT07587723

• Daratumumab versus rituximab for children with primary immune thrombocytopenia

  This study will test whether daratumumab works better than rituximab to increase platelet counts in children aged 6–17 with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07362238

• Daratumumab plus rituximab for adults with relapsed or refractory immune thrombocytopenia

  This treatment combines daratumumab (an anti‑CD38 antibody) with rituximab to see if it raises platelet counts in adults with ITP who haven't responded to steroids and other therapies.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07362199

• Daratumumab versus rituximab for adult primary immune thrombocytopenia

  This trial will test whether daratumumab (an anti‑CD38 antibody) works better than rituximab for adults with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07297563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.