Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children
NCT ID: NCT05520892
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
580 participants
INTERVENTIONAL
2022-10-06
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low-dose intravenous immunoglobulin
0.4g/kg.d, d1-5
intravenous immunoglobulin
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
high-dose intravenous immunoglobulin
1.0g/kg.d, d1-2
intravenous immunoglobulin
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
Interventions
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intravenous immunoglobulin
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
Eligibility Criteria
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Inclusion Criteria
2. Age \> 28 days and ≤ 14 years old
3. PLT\<20×109/L
4. Have signed the informed consent
Exclusion Criteria
2. Received glucocorticoid or IVIG therapy within 6 months
3. Weight \> 40kg
4. Menstrual female patients
5. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
6. Patients who have received radiotherapy and chemotherapy
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 -
29 Days
14 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Xiamen University
OTHER
Zhangzhou Affiliated Hospital of Fujian Medical University
OTHER
Quanzhou First Hospital
OTHER
Nanping First Hospital Affiliated to Fujian Medical University
UNKNOWN
The Second Hospital of Anhui Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Longyan City First Hospital
OTHER
The Affiliated Hospital of Putian University
OTHER
Fujian Medical University Union Hospital
OTHER
Responsible Party
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Locations
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Children with newly dignosed ITP
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022YF024-01
Identifier Type: -
Identifier Source: org_study_id
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