Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

NCT06577909 | Recruiting Phase 2

• 1 other identifier: PKU-ITP023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Keywords

immune thrombocytopenia; pregnancy; therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Complete Response

  4 weeks

• Early response

  1 week

• relapse

  1 year

• Time to Response

  4 weeks

• Time to relapse (duration of efficacy)

  1 year

Study Arms (2)

The combination group

EXPERIMENTAL

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

Drug: Prednisone; Drug: IVIg

The prednisone group

ACTIVE COMPARATOR

Prednisone 20mg per day×4 weeks

Drug: Prednisone

Interventions

Prednisone 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.

Also known as: Pre

The combination group; The prednisone group

IVIg 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

Also known as: intravenous immunoglobulin

The combination group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Prednisone; Lead; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Metals; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaohui Zhang, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, Professor

CONTACT

+8613522338836; zhangxh100@sina.com

Haixia Fu, MD

CONTACT

13581830157; fuhaixia_210@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Institute of Hematology

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: October 19, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

CN (1)