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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项行业发起的临床研究旨在评价GLP-2类似物替度鲁肽与安慰剂相比在肠外营养（PN）依赖性短肠综合征（SBS）受试者中的疗效、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、平行组、多国、多中心研究。受试者将被随机分配至替度鲁肽组或安慰剂组。将有一次筛选访视;一个PN减量和最佳剂量调整期;一个显示PN稳定给药4周的基线期;一个24周的后续给药期;对于未继续参加扩展研究的受试者，一个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.