A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate
Eligibility
Participation Requirements
Sex: All
Minimum Age: 29 days
Maximum Age: 14
Healthy Volunteers: f
View:
• Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
• Age \> 28 days and ≤ 14 years old
• PLT\<20×109/L
• Have signed the informed consent
Locations
Other Locations
China
Children with newly dignosed ITP
RECRUITING
Fuzhou
Contact Information
Primary
Shaohua Le, Master's degree
lele883@sina.com
8613365917129
Time Frame
Start Date: 2022-10-06
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 580
Treatments
Experimental: low-dose intravenous immunoglobulin
0.4g/kg.d, d1-5
Active_comparator: high-dose intravenous immunoglobulin
1.0g/kg.d, d1-2
Related Therapeutic Areas
Sponsors
Leads: Fujian Medical University Union Hospital
Collaborators: The First Affiliated Hospital of Xiamen University, The Second Hospital of Anhui Medical University, The Affiliated Hospital of Putian University, Quanzhou First Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, The Affiliated Hospital Of Guizhou Medical University, Nanping First Hospital Affiliated to Fujian Medical University, Longyan City First Hospital