Treatment to induce immune tolerance in ITP patients after stopping TPO-RA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether maintaining a high platelet count in patients with primary immune thrombocytopenia (ITP) after treatment with thrombopoietin receptor agonists (TPO-RA) can lead to immune tolerance. Patients who achieve a complete response with a platelet count of at least 100 x 10^9/L will continue treatment to maintain platelet levels between 300-600 x 10^9/L. After 24 weeks, those with stable platelet counts will enter a reduction phase, aiming to sustain platelet levels without ongoing treatment. The goal is to determine if this approach can achieve a sustained response off treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years old, regardless of gender;
2. Patients with newly diagnosed or persistent primary ITP who have shown inadequate response or relapse following first-line corticosteroid treatment with or without IVIg;
3. Complete response (PLT \> 100 × 10\^9/L) achieved after hetrombopag treatment at doses of 2.5mg-7.5mg per day;
4. Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.

Exclusion Criteria:

1. Age\>50 years old;
2. Those who are contraindicated to taking aspirin;
3. Previous arterial or venous thrombosis history (including coronary atherosclerotic heart disease, ischemic stroke, deep vein thrombosis or pulmonary embolism, etc.) or clinical symptoms and medical history indicate thrombophilia;
4. Risk factors of cardiovascular diseases such as hypertension, diabetes and hyperlipidemia;
5. Heart disease occurring within the first 3 months of screening, including congestive heart failure classified as III/IV by the New York Heart Association (NHYA), arrhythmias or myocardial infarction requiring medication, or arrhythmias known to increase the risk of thrombotic events (such as atrial fibrillation), or prolonged QT interval (QTc) after subject correction (QTc\>450 milliseconds, or QTc\>480 milliseconds in subjects with bundle branch block)
6. Patients currently undergoing anticoagulant therapy or antiplatelet therapy;
7. Female patients receiving estrogen replacement therapy or oral contraceptives;
8. Patients with past or current malignant tumors;
9. Secondary thrombocytopenia, such as myelodysplastic syndrome, immune disorders such as systemic lupus erythematosus, early aplastic anemia, atypical aplastic anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, and other causes of thrombocytopenia;
10. The results of bone marrow biopsy during the screening period indicate that the bone marrow fibrosis MF is ≥ 2 (Thieleja 2005, the European expert consensus bone marrow fibrosis scoring standard), or that bone marrow biopsy suggests the presence of other primary diseases that can cause thrombocytopenia besides ITP;
11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are three times higher than the upper limit of normal values, total bilirubin is three times higher than the upper limit of normal values, and blood creatinine is 1.5 times higher than the upper limit of normal values;
12. Have a history of liver cirrhosis or portal hypertension;
13. Uncontrollable infections;
14. Hepatitis B surface antigen positive or previous history of hepatitis B, and in the past 3 months, accompanied by HBV-DNA ≥ 2000IU/ML; those with positive hepatitis C antibody, HCV-RNA positive in the past 3 months;
15. Individuals who test positive for antibodies against human immunodeficiency virus or specific antibodies against Treponema pallidum;
16. Individuals who are known to be allergic to the drug itself or its excipients;
17. Breastfeeding or pregnant women or female patients planning to conceive during the study period; 18）Other situations determined by the researcher as unsuitable for participation in this study

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Tienan Zhu, M.D. — Peking Union Medical College Hospital
• Study coordinator: Tienan Zhu, M.D.
• Email: zhutn@pumch.cn
• Phone: 01069155027

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GL-2045 safety and blood-count help for adults with ITP

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• Eltrombopag use in adults with primary ITP: real-world patterns and outcomes

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• Daratumumab versus rituximab for children with primary immune thrombocytopenia

  This study will test whether daratumumab works better than rituximab to increase platelet counts in children aged 6–17 with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07362238

• Daratumumab plus rituximab for adults with relapsed or refractory immune thrombocytopenia

  This treatment combines daratumumab (an anti‑CD38 antibody) with rituximab to see if it raises platelet counts in adults with ITP who haven't responded to steroids and other therapies.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07362199

• Daratumumab versus rituximab for adult primary immune thrombocytopenia

  This trial will test whether daratumumab (an anti‑CD38 antibody) works better than rituximab for adults with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07297563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.