NCT05522465
Recruiting
Phase 4
Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia
Overview
- Phase
- Phase 4
- Intervention
- Prednisone
- Conditions
- Immune Thrombocytopenia
- Sponsor
- Fujian Medical University Union Hospital
- Enrollment
- 608
- Locations
- 1
- Primary Endpoint
- initial treatment response
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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)
Investigators
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
Arms & Interventions
prednisone group
prednisone 4mg/kg.d
Intervention: Prednisone
Dexamethasone
Dexamethasone 0.6mg/kg.d
Intervention: Dexamethasone
Outcomes
Primary Outcomes
initial treatment response
Time Frame: 30 days after treatment
Platelet count after glucocorticoid therapy 1 month
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](1 month)
Study Sites (1)
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