A STUDY OF THE EFFICACY AND SAFETY OF TEDUGLUTIDE IN SUBJECTS WITH PARENTAL N

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项由业界发起的临床研究的目的是评估GLP-2类似物替都卢肽与安慰剂在肠外营养(PN)依赖型短肠综合征(SBS)患者中的疗效、安全性、耐受性和药代动力学。这是一项随机、双盲、安慰剂对照、平行分组、多国、多中心研究。受试者将被随机给予替杜鲁肽或安慰剂。将有一次筛查访问；一个PN减少和最优化时期；一个基线时期，表明PN的稳定管理4周；随后的剂量时期为24周；以及，对于没有继续进行扩展研究的受试者，为期4周的随访期。

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 objective of this INDUSTRY-INITIATED clinical study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of the GLP-2 analog teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS). This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter study. Subjects will be randomized to either teduglutide or placebo. There will be a screening visit; a PN reduction and optimization period; a baseline period which demonstrates stable administration of PN for 4 weeks; a subsequent dosing period of 24 weeks; and, for subjects not going on to the extension study, a follow-up period of 4 weeks.