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

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

Recruiting
14 years and older
All
Phase N/A

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Overview

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 .

Description

The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment.

100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.

Eligibility

Inclusion Criteria:

  • Men and women greater than or equal to 14 years of age.
  • Participants diagnosed with primary immune thrombocytopenia with two platelet counts of < 30x10^9/L or with bleeding at least 7 days apart,do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).
  • Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-day rhTPO with no response to treatment (platelet count < 30×109/L after treatment, or platelet count increase less than twice the baseline value, or with bleeding)
  • Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.

Exclusion Criteria:

  • Patients diagnosed with secondary immune thrombocytopenia.
  • A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.
  • Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
  • Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
  • Have used rituximab in the past 3 months;
  • Splenectomy in recent 3 months;
  • Those who are not considered suitable for this study by the researcher;
  • Women who are pregnant or who intend to become pregnant in the near future are excluded.

Study details
    Primary Immune Thrombocytopenic Purpura

NCT04890041

Institute of Hematology & Blood Diseases Hospital, China

14 October 2025

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