NCT06168851 Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
| NCT ID | NCT06168851 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-12-28 |
| Primary Completion | 2025-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and/or TPO-RA, or those in whom no other second-line treatment options are suitable.
Eligibility Criteria
Inclusion Criteria: * Age 6 years and above, male or female * Conform to the diagnostic criteria of immune Thrombocytopenia (ITP) * Diagnosis of ITP ≥3 months, and with a platelet count of \<30 X 10\^9/L measured within 2 days prior to inclusion * Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs. * The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration * Signed and dated written informed consent * With normal hepatic and renal functions * ECOG physical state score ≤ 2 points * Cardiac function of the New York Society of Cardiac Function ≤ 2 * Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyc