Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 29 days
Maximum Age: 14
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Children with newly dignosed ITP
RECRUITING
Fujian
Contact Information
Primary
Yongzhi Zheng, PhD
brandy850728@163.com
8613459414385
Time Frame
Start Date: 2022-10-11
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 608
Treatments
Experimental: prednisone group
prednisone 4mg/kg.d
Active_comparator: Dexamethasone
Dexamethasone 0.6mg/kg.d
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