RecruitingNot ApplicableNCT04890041

TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years

Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

100 participants

Start Date

May 30, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is for people with immune thrombocytopenia (ITP), a condition where the immune system attacks platelets — the cells that help blood clot. Specifically, it's for people whose ITP has not responded to standard first-line treatments or to certain platelet-boosting medications. The study is testing different thrombopoietin receptor agonist (TPO-RA) drugs — medications that stimulate the body to produce more platelets. You may be eligible if: • You are 14 years of age or older • You have been diagnosed with primary ITP with very low platelet counts (below 30×10⁹/L) or have bleeding symptoms • You have already tried first-line treatment and one or more standard platelet-boosting drugs without adequate response You may NOT be eligible if: • You have secondary ITP (caused by another disease) • You have a history of blood clots, heart attack, stroke, or certain autoimmune diseases • You have significant liver or kidney disease • You are allergic to the study drugs • You have had rituximab treatment or a splenectomy in the past 3 months • You are pregnant or planning to become pregnant soon 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

DRUGTPO-RA

The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10\^9/L and 150×10\^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10\^9/L, the treatment was stopped. If the platelet count is more than 400×10\^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT04890041


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