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

NCT05520892 | Recruiting Phase 4

• 1 other identifier: 2022YF024-01
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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

Conditions

Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

Outcome Measures

Primary Outcomes (1)

• early response to treatment

  Platelet counts after 7 days of IVIG treatment

  7 days after treatment

Secondary Outcomes (2)

• Economic Indicators

  1 week

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  1 week

Study Arms (2)

low-dose intravenous immunoglobulin

EXPERIMENTAL

0.4g/kg.d, d1-5

Drug: intravenous immunoglobulin

high-dose intravenous immunoglobulin

ACTIVE COMPARATOR

1.0g/kg.d, d1-2

Drug: intravenous immunoglobulin

Interventions

intravenous immunoglobulin DRUG

To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia

high-dose intravenous immunoglobulin; low-dose intravenous immunoglobulin

Eligibility Criteria

• Age: 29 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

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

Study Sites (1)

Children with newly dignosed ITP

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Interventions

Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shaohua Le, Master's degree

CONTACT

8613365917129; lele883@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 30, 2022
• Study Start: October 6, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)