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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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50 × 10\^9/L with7.5mg/d × 28d, the patient will be withdrawn.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 If the PLT during two consecutive visits is less than 30 × 10\^9/L, the patient will be withdrawn.
Aspirin 100mg, qd
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGSustained response off treatment (SROT)
The percentage of participants with successful discontinuation of TPO-RAs after tapering and discontinuation
Time frame: 3 year
Quality of life (QoL)
The degree to which an individual is healthy, comfortable, and able to participate in or enjoy life events according to the MOS 36-item short-form health survey (SF-36) at week1, week24 and week56 (±5 d).
Time frame: 3 year
Duration of Complete response (DCR)
The time from the first assessment of complete resonse (platelet count ≥ 100 × 10\^9/L, without bleeding) until the date of the first occurrence of progression, or until the date of death.t
Time frame: 3 year
Duration of Response (DoR)
The time from the first assessment of response (platelet count ≥ 50 × 10\^9/L) until the date of the first occurrence of progression, or until the date of death.
Time frame: 3 year
Adverse events
The incidence and severity of thromboembolism, as well as other commonly used indicators such as abnormal clinical symptoms and vital signs, abnormalities observed in laboratory tests, are recorded.Toxicity will be graded according to NCI-CTC AE 5.0.
Time frame: 3 years
Bleeding events
Bleeding events occurring in patients due to ITP
Time frame: 3 years
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