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

Last updated: February 20, 2025
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

White Cell Disorders

Thrombosis

Dysfunctional Uterine Bleeding

Treatment

TPO-RA

Clinical Study ID

NCT04890041
IIT2020033
  • Ages > 14
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Men and women greater than or equal to 14 years of age.

  • Participants diagnosed with primary immune thrombocytopenia with two platelet countsof < 30x10^9/L or with bleeding at least 7 days apart,do not have evidence of othercauses 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-dayrhTPO with no response to treatment (platelet count < 30×109/L after treatment, orplatelet 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

Exclusion Criteria:

  • Patients diagnosed with secondary immune thrombocytopenia.

  • A history of arteriovenous thrombosis, disseminated intravascular coagulation,myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmunediseases, malignant tumors, liver cirrhosis and other diseases that were noteligible for inclusion.

  • Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times ofthe upper limit of normal; b. alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients withrenal disease (serum creatinine ≥ 1.5 times the upper limit of normal);

  • Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, orany 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 areexcluded.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: TPO-RA
Phase:
Study Start date:
May 30, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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