Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

Phase 2

Recruiting

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Prednisone; Drug: IVIg

• Registration Number: NCT06577909
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2023-10-19
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The combination group	Prednisone	Prednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days
The prednisone group	Prednisone	Prednisone 20mg per day×4 weeks
The combination group	IVIg	Prednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Complete Response	4 weeks	Platelet count ≥100×10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding
Time to relapse (duration of efficacy)	1 year	The time from achievement of CR or R to time of relapse
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
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
Early response	1 week	Platelet count ≥30×10\^9/L and at least doubling baseline at 1 week
Platelet counts at delivery	At delivery	Platelet counts at delivery

Trial Locations

Locations (1)

Peking University Insititute of Hematology, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China