Short-course High-dose Prednisone and Dexamethasone in Children With ITP
1 other identifier
interventional
608
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2022
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedStudy Start
First participant enrolled
October 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedMay 16, 2024
February 1, 2024
2.9 years
August 29, 2022
May 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
initial treatment response
Platelet count after glucocorticoid therapy 1 month
30 days after treatment
Secondary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
1 month
Study Arms (2)
prednisone group
EXPERIMENTALprednisone 4mg/kg.d
Dexamethasone
ACTIVE COMPARATORDexamethasone 0.6mg/kg.d
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fujian Medical University Union Hospitallead
- The First Affiliated Hospital of Xiamen Universitycollaborator
- Zhangzhou Affiliated Hospital of Fujian Medical Universitycollaborator
- Quanzhou First Hospitalcollaborator
- Nanping First Hospital Affiliated to Fujian Medical Universitycollaborator
- The Second Hospital of Anhui Medical Universitycollaborator
- The Affiliated Hospital Of Guizhou Medical Universitycollaborator
- Longyan City First Hospitalcollaborator
- The Affiliated Hospital of Putian Universitycollaborator
Study Sites (1)
Children with newly dignosed ITP
Fujian, Fujian, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2022
First Posted
August 31, 2022
Study Start
October 11, 2022
Primary Completion
August 31, 2025
Study Completion (Estimated)
August 31, 2026
Last Updated
May 16, 2024
Record last verified: 2024-02