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Short-course High-dose Prednisone and Dexamethasone in Children With ITP

Recruiting
29 - 14 years of age
Both
Phase 4

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Overview

Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)

Eligibility

Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:

  1. Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
  2. Age > 28 days and ≤ 14 years old
  3. Untreated PLT<20×109/L, or PLT<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
  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
             thrombopoietic drugs (recombinant human thrombopoietin, eltrombopag, etc.)
          2. Received glucocorticoid therapy within 6 months
          3. Menstrual female children
          4. Patients with underlying diseases such as tumor diseases, autoimmune diseases or
             genetic diseases
          5. Patients who have received radiotherapy and chemotherapy
          6. There are contraindications to the use of glucocorticoids (hypertension, glaucoma,
             peptic ulcer, etc.)
          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

Immune Thrombocytopenia, Glucocorticoids, Child, Only

NCT05522465

Fujian Medical University Union Hospital

25 May 2024

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