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

NCT04890041•Institute of Hematology & Blood Diseases Hospital, China

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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 .

Detailed 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

Age

14 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 30, 2021

Primary Completion Date

November 30, 2025

Completion Date

December 31, 2025

Last Updated

February 24, 2025

Enrollment

100

ESTIMATED participants

Conditions

Primary Immune Thrombocytopenic Purpura

Interventions

TPO-RA

DRUG

Contacts

Wei Liu

CONTACT

+82223909240 liuwei1@ihcams.ac.cn

Lei Zhang

CONTACT

+82223909240 zhanglei1@ihcams.ac.cn

A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP

NCT04428255

Primary Immune Thrombocytopenic Purpura

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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