CAMPTH-1H&TACROLIMUS FOLLOWED BY IMMUNOSUPPRESS WITHDRAWAL IN LIVER TRANSPLANTS

坎普斯-1H

• 批准号: 7604416
• 负责人: James F. Trotter
• 金额: $ 0.1万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604416
• 关键词: Computer Retrieval of Information on Scientific Projects Database; Consent; Dose; Funding; Grant; Immunosuppression; Institution; Liver; Monoclonal Antibody Campath-1H; Pharmaceutical Preparations; Prograf; Purpose; Research; Research Personnel; Resources; Source; Tacrolimus; Therapeutic immunosuppression; United States National Institutes of Health; Visit; Weaning; Withdrawal; immunosuppressed; liver function; liver transplantation; prevent; research study

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. The purpose of this research study is to determine if 2 doses of Campath-1H, followed by one anti-rejection drug called tacrolimus (Prograf), will be safe and effective in preventing rejection of the donor liver. This study will also evaluate the ability of the Campath-1H to induce "tolerance". Tolerance is when the body no longer tries to reject the transplanted liver even when you are not taking immunosuppression. During this study, the anti-rejection medication (tacrolimus) used to prevent rejection will be gradually withdrawn, beginning one year after liver transplant liver function is stable. If it is determined that the subject can gradually withdraw tacrolimus and then the subject will be re-consented to take part in the withdrawal portion of this study. The withdrawal component will last one year and involve weekly and bi-weekly visits to allow a gradual weaning of the tacrolimus.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是确定 2 剂 Campath-1H，随后使用一种名为他克莫司 (Prograf) 的抗排斥药物，是否能够安全有效地预防供体肝脏的排斥反应。 这项研究还将评估 Campath-1H 诱导“耐受性”的能力。耐受性是指即使您没有服用免疫抑制剂，身体也不再试图排斥移植的肝脏。在这项研究期间，用于预防排斥反应的抗排斥药物（他克莫司）将在肝移植肝功能稳定后一年开始逐渐停用。 如果确定受试者可以逐渐退出他克莫司，则受试者将重新同意参加本研究的退出部分。停药部分将持续一年，包括每周和每两周一次的就诊，以逐步戒断他克莫司。