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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    580
  • sponsor
    Fujian Medical University Union Hospital
Updated on 7 October 2022

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

Details
Condition Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment
Treatment Intravenous immunoglobulin
Clinical Study IdentifierNCT05520892
SponsorFujian Medical University Union Hospital
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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 -
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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