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

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

Recruiting
29-14 years
All
Phase 4

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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

Eligibility

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 -

Study details
    Newly Diagnosed Immune Thrombocytopenia in Children
    First Line Treatment

NCT05520892

Fujian Medical University Union Hospital

24 May 2024

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