NCT06577909 Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
| NCT ID | NCT06577909 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2024-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-50 years old; 2. Meet the diagnostic criteria for immune thrombocytopenia; 3. Pregnant women with ITP without ITP-specific treatments during pregnancy; 4. Gestational weeks ≥12 weeks; 5. Platelet count \<30×10\^9/L, accompanied with or without bleeding symptoms. 6. Willing and able to sign written informed consent. Exclusion Criteria: 1. Have a known diagnosis of other autoimmune diseases, confirmed medical history or laboratory findings within positive anti-nuclear antibodies (\>1:80), anti-cardiolipin antibodies, lupus anticoagulant factors or direct Coombs' test. 2. Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy. 3. Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on. 4. With other underlying diseases that may cause