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Recruiting NCT05520892

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

Phase IV Interventional Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intravenous immunoglobulin.
Who it may be relevant to
Registry conditions: Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment. Basic parameters: 29 Days — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • early response to treatment [Time frame: 7 days after treatment]
Secondary outcome measures (2)
  • Economic Indicators [Time frame: 1 week]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 1 week]

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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Children with newly dignosed ITP — Fuzhou

Identifiers

NCT: NCT05520892 · 2022YF024-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗