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

Phase 4

Recruiting

• Conditions: Child, Only; Immune Thrombocytopenia; Glucocorticoids
• Interventions: Drug: Prednisone; Drug: Dexamethasone

• Registration Number: NCT05522465
• Lead Sponsor: Fujian Medical University Union Hospital

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2022-10-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 608

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prednisone group	Prednisone	prednisone 4mg/kg.d
Dexamethasone	Dexamethasone	Dexamethasone 0.6mg/kg.d

Primary Outcome Measures

Name	Time	Method
initial treatment response	30 days after treatment	Platelet count after glucocorticoid therapy 1 month

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	1 month	Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy

Trial Locations

Locations (1)

Children with newly dignosed ITP; 🇨🇳 Fujian, Fujian, China