NCT06478537 TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
| NCT ID | NCT06478537 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2027-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 56 participants in total. It began in 2024-06-20 with a primary completion date of 2027-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Tienan Zhu, M.D.
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT06478537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06478537 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06478537 currently recruiting?
Yes, NCT06478537 is actively recruiting participants. Contact the research team at zhutn@pumch.cn for enrollment information.
Where is the NCT06478537 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06478537 clinical trial?
NCT06478537 is sponsored by Peking Union Medical College Hospital. The principal investigator is Tienan Zhu, M.D. at Peking Union Medical College Hospital. The trial plans to enroll 56 participants.