General considerations for clinical trials of human plasma-derived von Willebrand factor
10.13200/j.cnki.cjb.004580
- VernacularTitle:人血来源血管性血友病因子的临床试验考虑
- Author:
WANG Yanlin
- Publication Type:Journal Article
- Keywords:
Von Willebrand factor(VWF);
Von Willebrand disease(VWD);
Clinical trials;
Efficacy evaluation;
Safety evaluation
- From:
Chinese Journal of Biologicals
2025;38(10):1274-1280
- CountryChina
- Language:Chinese
-
Abstract:
At present, a number of human plasma-derived preparations containing von Willebrand factor(VWF) have been approved for market in foreign countries, and no such preparations have been listed in China, but clinical trials for such preparations have been prepared or carried out. This paper mainly draws on the research and development experience of blood-derived VWF in Europe and the United States, focuses on analyzing the technical requirements for quantitative detection and clinical trials of such preparations, and discusses the contents that should be paid attention to in clinical trials of domestic blood-derived VWF products for the treatment of von Willebrand disease(VWD), so as to provide reference for domestic VWF products to carry out related clinical trials.
