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

Last updated: May 14, 2024
Sponsor: Fujian Medical University Union Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Dysfunctional Uterine Bleeding

Thrombosis

Treatment

Prednisone

Dexamethasone

Clinical Study ID

NCT05522465
2022YF025-01
  • Ages 29-14
  • All Genders

Study Summary

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 Criteria

Inclusion

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

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 hemorrhagerequiring emergency treatment, such as simultaneous use of platelet transfusion andthrombopoietic 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 orgenetic 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 thataffect the patient's life safety and compliance, and affect informed consent,research participation, follow-up or interpretation of results

Study Design

Total Participants: 608
Treatment Group(s): 2
Primary Treatment: Prednisone
Phase: 4
Study Start date:
October 11, 2022
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Children with newly dignosed ITP

    Fujian, Fujian
    China

    Active - Recruiting

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