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Clinical Trials in China / NCT04890041
Recruiting Not applicable

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

NCT04890041 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Not applicable
Started
2021-05-30
Last updated
2025-02-24

Condition(s) studied

Primary Immune Thrombocytopenic Purpura

Investigational drug(s) / intervention(s)

TPO-RA →

TPO-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.

Study 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

Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital Tianjin Tianjin Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04890041 on ClinicalTrials.gov ↗ ← All trials in China