Comparing prednisone plus IVIg to prednisone alone for treating ITP in pregnant women

Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy

This study is testing whether combining prednisone with IVIg is better than using prednisone alone to treat pregnant women with immune thrombocytopenia.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06577909 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, open-label study designed to evaluate the efficacy and safety of combining prednisone with intravenous immunoglobulin (IVIg) versus using prednisone alone in treating immune thrombocytopenia (ITP) during pregnancy. A total of 100 pregnant participants with untreated ITP will be randomly assigned to receive either the combination therapy or prednisone monotherapy for four weeks. The study will assess platelet counts, bleeding symptoms, and adverse events for both the mothers and their newborns throughout the treatment period. The goal is to determine which treatment approach is more effective and safer for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18-50 years with a diagnosis of immune thrombocytopenia and a platelet count below 30×10^9/L.

Not a fit: Patients with other autoimmune diseases or those whose thrombocytopenia is caused by pregnancy-specific conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for pregnant women suffering from immune thrombocytopenia, potentially improving maternal and neonatal health outcomes.

How similar studies have performed: While there have been studies on ITP treatments, this specific combination therapy approach during pregnancy is novel and has not been extensively tested.

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 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;
5. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
6. With severe heart, kidney, liver or respiratory dysfunction;
7. With the medical history of mental illness;
8. Have allergic reaction to prednisone or IVIg;

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Principal investigator: Xiaohui Zhang, Professor — Peking University Insititute of Hematology, Peking University People's Hospital
• Study coordinator: Xiaohui Zhang, Professor

Conditions Immune Thrombocytopenia; immune thrombocytopenia; pregnancy; therapy