Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

Recruiting now · Phase 2

Conditions studied: Immune Thrombocytopenia

In brief

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.

Key facts

Study ID

NCT06577909

Run by

Peking University People's Hospital

People needed

100

Starts

2023-10-19

Expected to finish

2025-12-31

Last updated by the study team

2024-08-29

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Peking University Insititute of Hematology, Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.