Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

NCT ID: NCT06577909

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2025-12-31

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The combination group

Prednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

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.

IVIg

Intervention Type: DRUG

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

The prednisone group

Prednisone 20mg per day×4 weeks

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Pre; intravenous immunoglobulin

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice President of Peking University Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaohui Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University Insititute of Hematology, Peking University People's Hospital

Locations

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohui Zhang, Professor

Role: CONTACT

zhangxh100@sina.com

+8613522338836

Haixia Fu, MD

Role: CONTACT

fuhaixia_210@163.com

13581830157

Facility Contacts

Xiaohui Zhang, MD

Role: primary

zhangxh100@sina.com

+8613522338836

Haixia Fu, MD

Role: backup

fuhaixia_210@163.com

13581830157

Other Identifiers

PKU-ITP023

Identifier Type: -

Identifier Source: org_study_id