Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children

A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children

To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate

Study Overview

• Status: Recruiting
• Conditions: Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment
• Intervention / Treatment: Drug: intravenous immunoglobulin

• Study Type: Interventional
• Enrollment (Estimated): 580
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shaohua Le, Master's degree; Phone Number: 8613365917129; Email: lele883@sina.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Children with newly dignosed ITP
      • Contact: Shaohua Le, Master; Phone Number: 8613365917129; Email: lele883@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:

1. Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
2. Age > 28 days and ≤ 14 years old
3. PLT<20×109/L
4. Have signed the informed consent

Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:

1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy
2. Received glucocorticoid or IVIG therapy within 6 months
3. Weight > 40kg
4. Menstrual female patients
5. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
6. Patients who have received radiotherapy and chemotherapy
7. There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results -

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: low-dose intravenous immunoglobulin; 0.4g/kg.d, d1-5	Drug: intravenous immunoglobulin; To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
Active Comparator: high-dose intravenous immunoglobulin; 1.0g/kg.d, d1-2	Drug: intravenous immunoglobulin; To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early response to treatment	Platelet counts after 7 days of IVIG treatment	7 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic Indicators	Calculate the total amount of IVIG used in 1 week (weight normalized)	1 week
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events in 1 week	1 week

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Collaborators: The Affiliated Hospital Of Guizhou Medical University; The Second Hospital of Anhui Medical University; The First Affiliated Hospital of Xiamen University; Longyan City First Hospital; Zhangzhou Affiliated Hospital of Fujian Medical University; Quanzhou First Hospital Affiliated to Fujian Medical University; Nanping First Hospital Affiliated to Fujian Medical University; The Affiliated Hospital of Putian University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: August 28, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• 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; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: 2022YF024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No