Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisone, IVIg.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy
Overview
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.
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 groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.
Interventions
- Drug Prednisone
Prednisone po, 20mg per day for 4 weeks, if response (Plt 30-100×100\^g/L), gradually taper to the maintenance dose of 5-10mg per day until 6 weeks after delivery; if not response, gradually taper to withdrawal. - Drug IVIg
IVIg 400mg/kg (≤20g for the total dose) per day for 5 days, and repeated in the case of lack of response by day 14
Primary outcome measures
- Overall Response [Time frame: 4 weeks]
Secondary outcome measures (8)
- Complete Response [Time frame: 4 weeks]
- Early response [Time frame: 1 week]
- relapse [Time frame: 1 year]
- Time to Response [Time frame: 4 weeks]
- Time to relapse (duration of efficacy) [Time frame: 1 year]
- Platelet counts at delivery [Time frame: At delivery]
- Platelet counts of newborns [Time frame: up to 42 days per newborn]
- Adverse events in parturients [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Insititute of Hematology, Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06577909 · PKU-ITP023