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Recruiting NCT05522465

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

Phase IV Interventional Immune Thrombocytopenia Glucocorticoids Child, Only

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: Prednisone, Dexamethasone.
Who it may be relevant to
Registry conditions: Immune Thrombocytopenia, Glucocorticoids, Child, Only. 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

Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia

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)

Interventions

  • Drug Prednisone
    Prednisone 4mg/kg.d, d1-4
  • Drug Dexamethasone
    Dexamethasone 0.6mg/kg.d, d1-4

Primary outcome measures

  • initial treatment response [Time frame: 30 days after treatment]
Secondary outcome measures (1)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 1 month]

Eligibility criteria

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

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

Identifiers

NCT: NCT05522465 · 2022YF025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗