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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05522465
Other study ID # 2022YF025-01
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
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