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Authors
Fang, Lijun
Sun, Ting
Zhou, Hu
Jie, Guitao
Fu, Jiaping
Yang, Enqin
Zhou, Zeping
Liu, Ligen
Zhang, Jingyu
Qian, Shenxian
Chen, Yun
Liu, Ling
Gu, Jian
Kong, Fanliang
Huang, Ruibin
Chen, Yunfei
Zhang, Lei
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Funding
Funding for this research was provided by:
National Natural Science Foundation of China (82104618)
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Article History
Received: 8 December 2024
Accepted: 28 April 2025
First Online: 10 May 2025
Declarations
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: The protocol for the clinical study titled “An Open-Label, Multicenter Clinical Study of the Efficacy and Safety of Intravenous Human Immunoglobulin (pH4, 10%) (Chromatography) in Patients with Primary Immune Thrombocytopenia” (ChiCTR2300069388) and the inclusion of patients treated with the 5% IVIg regimen from a simultaneous national cohort study (ClinicalTrials.gov ID: NCT04645199) were approved by the institutional review boards or independent ethics committees of all participating centers. The study adhered to the principles outlined in the Declaration of Helsinki and the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences). Written informed consent needed was obtained from all participating patients prior to their inclusion in the study.
: The authors declare no competing interests.
: The clinical study evaluating 10% IVIg is registered on Chinese Clinical Trial Registry with the registration number ChiCTR2300069388. Additionally, the longitudinal cohort study of 5% IVIg has been registered on ClinicalTrials.gov under the registration number NCT04645199.
