Actively Recruiting
Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
Led by Peking University People's Hospital · Updated on 2024-08-29
100
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-50 years old
- Diagnosed with immune thrombocytopenia
- Pregnant with ITP and no prior ITP-specific treatments during this pregnancy
- Gestational age of at least 12 weeks
- Platelet count less than 30 x 10^9/L, with or without bleeding symptoms
- Able and willing to sign written informed consent
You will not qualify if you...
- Diagnosed with other autoimmune diseases or positive antibody tests (ANA >1:80, anti-cardiolipin antibodies, lupus anticoagulant, or positive Coombs' test)
- Thrombocytopenia caused by pregnancy-specific conditions such as gestational thrombocytopenia, preeclampsia, HELLP syndrome, or acute fatty liver of pregnancy
- Secondary thrombocytopenia due to drugs, vaccines, lymphoproliferative disorders, severe infection, liver cirrhosis, or similar causes
- Other diseases that may cause thrombocytopenia including malignancies, megaloblastic anemia, aplastic anemia, myelodysplasia, myeloid fibrosis, DIC, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
- Current infection with HIV, hepatitis B, or hepatitis C viruses
- Severe heart, kidney, liver, or respiratory dysfunction
- History of mental illness
- Allergic reaction to prednisone or IVIg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
X
Xiaohui Zhang, Professor
CONTACT
H
Haixia Fu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here