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

NCT06478537 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-06-27

No results posted yet for this study

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.

Conditions

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50 × 10\^9/L with7.5mg/d × 28d, the patient will be withdrawn.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 If the PLT during two consecutive visits is less than 30 × 10\^9/L, the patient will be withdrawn.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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Tienan Zhu, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2027-06-20
Completion
2027-06-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478537 on ClinicalTrials.gov