RecruitingPhase 2NCT06281327

Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia

A Prospective, One-arm and Open Clinical Study to Assess Efficacy and Safety of Avatrombopag in the Treatment of Pediatric Primary Immune Thrombocytopenia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

60 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating avatrombopag — a medication that stimulates platelet production — in children and adolescents with immune thrombocytopenia (ITP), a condition where the immune system mistakenly destroys platelets, causing low platelet counts and risk of bleeding. This study specifically looks at children who switched from a similar drug (eltrombopag) due to insufficient response or other reasons. **You may be eligible if...** - You are between 6 and 18 years old - You have been diagnosed with primary immune thrombocytopenia (ITP) - You previously received eltrombopag and switched to avatrombopag due to insufficient response, unstable platelet counts, or personal preference - Your heart function is adequate (New York Heart Association class ≤ 2) **You may NOT be eligible if...** - Your low platelet count is caused by another condition (not primary ITP) - You have significant liver, kidney, or heart disease - You are allergic to avatrombopag - You received rituximab or had your spleen removed within the last 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAvatrombopag

After enrollment, all subjects receive Avatrombopag treatment. The initial dose of Avatrombopag administration was an oral 10 mg (\<30kg) or 20mg (≥30kg) once daily in all participants. ps. For subjects weighing ≥30kg, the dose can be started from 40mg once daily if the platelet count is \< 10×10\^9/L or if there is severe bleeding or risk of bleeding. Complete blood count including platelet count was done once a week. The dose of Avatrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count was less than 30×10\^9/L for 2 weeks, avatrobopag was gradually increased. If the platelet count was greater than 150 x 10\^9/L, avatrobopag was gradually reduced. If the platelet count \>250×10\^9/L, avatrobopag will be stoped until the platelet count \<100×10\^9/L.


Locations(1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, China

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NCT06281327


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