Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy (IVIg)

Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Thrombocytopenia
• Intervention / Treatment: Drug: Prednisone; Drug: IVIg

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haixia Fu, MD; Phone Number: 13581830157; Email: fuhaixia_210@163.com
• Study Contact Backup: Name: Xiaohui Zhang, Professor; Phone Number: +8613522338836; Email: zhangxh100@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Peking University Insititute of Hematology, Peking University People's Hospital
      • Principal Investigator: Xiaohui Zhang, MD
      • Contact: Haixia Fu, MD; Phone Number: 13581830157; Email: fuhaixia_210@163.com
      • Contact: Xiaohui Zhang, MD; Phone Number: +8613522338836; Email: zhangxh100@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The combination group; Prednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days	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.; Other Names: Pre; 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; Other Names: intravenous immunoglobulin
Active Comparator: The prednisone group; Prednisone 20mg per day×4 weeks	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.; Other Names: Pre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response	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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet counts at delivery	Platelet counts at delivery	At delivery
Complete Response	Platelet count ≥100×10^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding	4 weeks
Early response	Platelet count ≥30×10^9/L and at least doubling baseline at 1 week	1 week
relapse	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	1 year
Time to Response	The day achieving OR	4 weeks
Time to relapse (duration of efficacy)	The time from achievement of CR or R to time of relapse	1 year
Platelet counts of newborns	Platelet counts of d1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs	up to 42 days per newborn
Adverse events in parturients	up to 2 years per subject	2 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Xiaohui Zhang, Professor, Peking University Insititute of Hematology, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pregnancy; therapy; immune thrombocytopenia
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Cytopenia; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Immunoglobulins; Immunoglobulins, Intravenous; Prednisone; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: PKU-ITP023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No