Status:
RECRUITING
Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
Lead Sponsor:
Peking University People's Hospital
Conditions:
Immune Thrombocytopenia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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 thromboc...
Detailed Description
The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two g...
Eligibility Criteria
Inclusion
- Age 18-50 years old;
- Meet the diagnostic criteria for immune thrombocytopenia;
- Pregnant women with ITP without ITP-specific treatments during pregnancy;
- Gestational weeks ≥12 weeks;
- Platelet count \<30×10\^9/L, accompanied with or without bleeding symptoms.
- Willing and able to sign written informed consent.
Exclusion
- 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.
- Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy.
- Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on.
- With other underlying diseases that may cause thrombocytopenia, such as: malignant disease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloid fibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, Hemolytic uremic syndrome, disseminated intravascular coagulation and so on;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- With severe heart, kidney, liver or respiratory dysfunction;
- With the medical history of mental illness;
- Have allergic reaction to prednisone or IVIg;
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06577909
Start Date
October 19 2023
End Date
December 31 2025
Last Update
August 29 2024
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010