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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522465
• Other study ID #: 2022YF025-01
• Status: Recruiting
• Phase: Phase 4
• Start date: October 11, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: February 2024
• Source: Fujian Medical University Union Hospital
• Contact: Yongzhi Zheng, PhD
• Phone: 8613459414385
• Email: brandy850728[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 608
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Glucocorticoids
• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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

Locations

Country	Name	City	State
China	Children with newly dignosed ITP	Fujian	Fujian

Sponsors (9)

Lead Sponsor

Collaborator

Fujian Medical University Union Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	initial treatment response	Platelet count after glucocorticoid therapy 1 month	30 days after treatment
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy	1 month