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

• Status: Recruiting
• Trial end date: 2026-08-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University Union Hospital
• Collaborators: Longyan City First Hospital; Nanping First Hospital Affiliated to Fujian Medical University; Quanzhou First Hospital Affiliated to Fujian Medical University; The Affiliated Hospital Of Guizhou Medical University; The Affiliated Hospital of Putian University; The First Affiliated Hospital of Xiamen University; The Second Hospital of Anhui Medical University; Zhangzhou Affiliated Hospital of Fujian Medical University
• Treatments: Dexamethasone; Prednisone

Criteria

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