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

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ClinicalTrials.gov Identifier: NCT05520892

Recruitment Status : Recruiting

First Posted : August 30, 2022

Last Update Posted : March 1, 2023

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

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

Information provided by (Responsible Party):

Fujian Medical University Union Hospital

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

Condition or disease	Intervention/treatment	Phase
Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment	Drug: intravenous immunoglobulin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	580 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children
Actual Study Start Date :	October 6, 2022
Estimated Primary Completion Date :	August 31, 2025
Estimated Study Completion Date :	August 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Immune thrombocytopenia Thrombotic thrombocytopenic purpura

Drug Information available for: Globulin, Immune

Genetic and Rare Diseases Information Center resources: Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

early response to treatment [ Time Frame: 7 days after treatment ]
Platelet counts after 7 days of IVIG treatment

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	29 Days to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 -

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05520892

Contacts

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Contact: Shaohua Le, Master's degree	8613365917129	lele883@sina.com

Locations

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

Sponsors and Collaborators