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

Primary Purpose

Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
intravenous immunoglobulin
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

Eligibility Criteria

29 Days - 14 Years (Child)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Children with newly dignosed ITPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low-dose intravenous immunoglobulin

high-dose intravenous immunoglobulin

Arm Description

0.4g/kg.d, d1-5

1.0g/kg.d, d1-2

Outcomes

Primary Outcome Measures

early response to treatment
Platelet counts after 7 days of IVIG treatment

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2022
Last Updated
February 28, 2023
Sponsor
Fujian Medical University Union Hospital
Collaborators
The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, Nanping First Hospital Affiliated to Fujian Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, Longyan City First Hospital, The Affiliated Hospital of Putian University
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1. Study Identification

Unique Protocol Identification Number
NCT05520892
Brief Title
Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children
Official Title
A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital
Collaborators
The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, Nanping First Hospital Affiliated to Fujian Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, Longyan City First Hospital, The Affiliated Hospital of Putian University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-dose intravenous immunoglobulin
Arm Type
Experimental
Arm Description
0.4g/kg.d, d1-5
Arm Title
high-dose intravenous immunoglobulin
Arm Type
Active Comparator
Arm Description
1.0g/kg.d, d1-2
Intervention Type
Drug
Intervention Name(s)
intravenous immunoglobulin
Intervention Description
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
Primary Outcome Measure Information:
Title
early response to treatment
Description
Platelet counts after 7 days of IVIG treatment
Time Frame
7 days after treatment
Secondary Outcome Measure Information:
Title
Economic Indicators
Description
Calculate the total amount of IVIG used in 1 week (weight normalized)
Time Frame
1 week
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence of Treatment-Emergent Adverse Events in 1 week
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria: Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment Age > 28 days and ≤ 14 years old PLT<20×109/L Have signed the informed consent Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study: Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy Received glucocorticoid or IVIG therapy within 6 months Weight > 40kg Menstrual female patients Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases Patients who have received radiotherapy and chemotherapy 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaohua Le, Master's degree
Phone
8613365917129
Email
lele883@sina.com
Facility Information:
Facility Name
Children with newly dignosed ITP
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaohua Le, Master
Phone
8613365917129
Email
lele883@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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