NCT06478537

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, ITP patients who has reached complete response (PLT ≥100 x 10\^9/L）after thrombopoietin receptor agonist (TPO-RA) therapy do not rush to reduce the drug dose, so that a higher level of platelet count can be maintained for a period of time. The treatment goal is to maintain the patient's platelet count at 300-600 × 10\^9/L, and adjust the dosage of hetrombopag (2.5mg/d\~7.5mg/d) based on the patient's platelet count. After 24-week TPO-RA treatment, all patients with a platelet count of ≥ 50 × 10\^9/L after two consecutive visits will enter an 8-week reduction period. All patients who successfully discontinued the drug and maintained their platelet count at ≥30×109/L entered the efficacy and safety follow-up period. The aim is to investigate whether this strategy could lead to the development or achievement of immune tolerance, achieving sustained response off treatment (SROT) (PLT≥50×109/L, no other ITP-specific medications, no bleeding) after TPO-RA discontinuation.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
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50 × 10\^9/L with7.5mg/d × 28d, the patient will be withdrawn.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

Timeline

• Start date: 2024-06-20
• Primary completion: 2027-06-20
• Completion: 2027-06-20
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

1 site across 1 country: China