PHASE II TRIAL ASSESS SFTY OF IMNOSPRSN W/DRAWAL IN LIVER TRNSPLNT RECIP W/HEP C

II 期试验评估 IMNOSPRSN 的 SFTY，并抽取肝脏 TRNSPLNT 配方和 HEP C

• 批准号: 7377858
• 负责人: James F. Trotter
• 金额: $ 0.19万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377858
• 关键词: PHASE; II; TRIAL; ASSESS; SFTY

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a prospective multicenter, open-label, randomized trial in which participants with hepatitis C-related liver failure undergo liver transplantation and receive immunosuppression induction with tacrolimus and corticosteroids. Corticosteroids are tapered in the 3 months after transplantation and tacrolimus is continued. Participants are regularly assessed for recurrence of hepatitis and for evidence of allograft rejection. One year after transplantation, participants suitable for withdrawal are randomly assigned to immunosuppression withdrawal or maintenance. Participants assigned to withdrawal undergo a scheduled taper over 1 year.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项前瞻性、多中心、开放标签、随机试验，其中丙型肝炎相关肝功能衰竭的参与者接受肝移植并接受他克莫司和皮质类固醇的免疫抑制诱导。移植后3个月内皮质类固醇逐渐减少，他克莫司继续使用。定期评估参与者的肝炎复发和同种异体移植排斥反应的证据。移植后一年，适合退出的参与者被随机分配到免疫抑制退出或维持。分配退出的受试者在1年内接受计划的减量。