Back to resultsShort-course High-dose Prednisone and Dexamethasone in Children With ITP
Primary Purpose
Immune Thrombocytopenia, Glucocorticoids, Child, Only
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Prednisone
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:
- 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
Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:
- 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
Sites / Locations
- Children with newly dignosed ITPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
prednisone group
Dexamethasone
Arm Description
prednisone 4mg/kg.d
Dexamethasone 0.6mg/kg.d
Outcomes
Primary Outcome Measures
initial treatment response
Platelet count after glucocorticoid therapy 1 month
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy
Full Information
NCT ID
NCT05522465
First Posted
August 29, 2022
Last Updated
February 28, 2023
Sponsor
Fujian Medical University Union Hospital
Collaborators
The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, Nanping First Hospital Affiliated to Fujian Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, Longyan City First Hospital, The Affiliated Hospital of Putian University
1. Study Identification
Unique Protocol Identification Number
NCT05522465
Brief Title
Short-course High-dose Prednisone and Dexamethasone in Children With ITP
Official Title
Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital
Collaborators
The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, Nanping First Hospital Affiliated to Fujian Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, Longyan City First Hospital, The Affiliated Hospital of Putian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia, Glucocorticoids, Child, Only
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
608 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prednisone group
Arm Type
Experimental
Arm Description
prednisone 4mg/kg.d
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 0.6mg/kg.d
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 4mg/kg.d, d1-4
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 0.6mg/kg.d, d1-4
Primary Outcome Measure Information:
Title
initial treatment response
Description
Platelet count after glucocorticoid therapy 1 month
Time Frame
30 days after treatment
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:
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
Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongzhi Zheng, PhD
Phone
8613459414385
Email
brandy850728@163.com
Facility Information:
Facility Name
Children with newly dignosed ITP
City
Fujian
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongzhi Zheng, PhD
Phone
8613459414385
Email
brandy850728@163.com
12. IPD Sharing Statement
Learn more about this trial
Short-course High-dose Prednisone and Dexamethasone in Children With ITP
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