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RECRUITING
NCT06478537
PHASE2

TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

The aim of this study was to observe whether maintaining a high level of platelet count after TPO-RA in patients with primary immune thrombocytopenia (ITP) can induce immune tolerance, develop immune balance in ITP patients, and enable patients to achieve a sustained response (SRoT) after TPO-RA discontinuation.

Official title: Thrombopoietin Receptor Agonist (TPO-RA) Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-06-20

Completion Date

2027-06-20

Last Updated

2024-06-27

Healthy Volunteers

No

Interventions

DRUG

Hetrombopag Olamine

Treatment period: 24-week Hetrombopag (2.5mg/d\~7.5mg/d) treatment. * Two consecutive visits with PLT\>600 × 10\^9/L: daily dose reduction of 2.5mg; If the lowest dose has been used, extend the dosing interval. * Two consecutive visits with PLT\<300 × 10\^9/L: increase the daily dose by 2.5mg until the maximum dose is reached. * Two consecutive visits with PLT\<50 × 10\^9/L: increase the daily dose by 2.5mg until the maximum dose is reached; If PLT is still\<50 × 10\^9/L with7.5mg/d × 28d, the patient will be withdrawn. Drug discontinuation period:8-week Hetrombopag (2.5mg/d\~7.5mg/d) reduction. Hetrombopag reduces by 2.5mg every 2 weeks, and after reducing to the minimum dose of 2.5mg/d x 2 weeks, it is changed to 2.5mg once every other day (Qod) treatment, with a maximum reduction time of 8 weeks. If the PLT during two consecutive visits is less than 30 × 10\^9/L, the patient will be withdrawn.

DRUG

Aspirin

Aspirin 100mg, qd

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China