Immune Thrombocytopenia
Conditions
Keywords
immune thrombocytopenia, pregnancy, therapy
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 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
DRUGPrednisone
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.
DRUGIVIg
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
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response | 4 weeks | Achieving a platelet count of≥30×10\^9/L and at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early response | 1 week | Platelet count ≥30×10\^9/L and at least doubling baseline at 1 week |
| relapse | 1 year | After the treatment is effective, the platelet count drops below 30×10\^9/L or drops to less than 2 times the basal value, or bleeding symptoms occur |
| Time to Response | 4 weeks | The day achieving OR |
| Complete Response | 4 weeks | Platelet count ≥100×10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding |
| Platelet counts at delivery | At delivery | Platelet counts at delivery |
| Platelet counts of newborns | up to 42 days per newborn | Platelet counts of d1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs |
| Adverse events in parturients | 2 years | up to 2 years per subject |
| Time to relapse (duration of efficacy) | 1 year | The time from achievement of CR or R to time of relapse |
Countries
China
Contacts
Primary ContactXiaohui Zhang, Professor
Backup ContactHaixia Fu, MD
Outcome results
None listed