[Translation] A phase III, open-label, trial evaluating the efficacy and safety of MK-8228 (letermovir) in preventing clinically significant cytomegalovirus (CMV) infection in Chinese adult recipients of CMV-seropositive allogeneic hematopoietic stem cell transplantation. single arm clinical trial
主要目的:评价来特莫韦预防临床显著CMV感染的有效性,通过截至移植后第24周(约6个月)发生临床显著CMV感染的受试者比例进行评估。
次要目的:
· 基于发生AE的受试者比例,评价使用来特莫韦治疗的安全性和耐受性。
· 评价来特莫韦预防临床显著CMV感染的有效性,通过截至移植后第14周(约100天)发生临床显著CMV感染的受试者比例进行评估。
· 通过以下指标,评价来特莫韦在预防临床显著CMV感染中的有效性: · 截至移植后第14周(约100天)和移植后第24周(约6个月),针对有记录的 CMV 病毒血症,开始 PET 治疗的受试者比例。 · 截至移植后第14周(约100天)和移植后第24周(约6个月),发生CMV病的受试者比例。 · 截至移植后第14周(约100天)和移植后第24周(约6个月),发生全因死亡的受试者比例。
[Translation] Primary objective: To evaluate the effectiveness of letermovir in preventing clinically significant CMV infection, as assessed by the proportion of subjects who developed clinically significant CMV infection by week 24 (approximately 6 months) post-transplantation.
Secondary purpose:
· To assess the safety and tolerability of treatment with Letermovir based on the proportion of subjects with AEs.
To evaluate the effectiveness of letermovir in preventing clinically significant CMV infection, as assessed by the proportion of subjects who developed clinically significant CMV infection by week 14 post-transplant (approximately 100 days).
The effectiveness of letermovir in the prevention of clinically significant CMV infection was assessed by: CMV viremia, proportion of subjects starting PET therapy. Proportion of subjects with CMV disease by week 14 (approximately 100 days) and week 24 (approximately 6 months) post-transplantation. · Proportion of subjects with all-cause death by week 14 (approximately 100 days) and week 24 (approximately 6 months) post-transplantation.