STUDY OF ORAL THERACLEC-TOTAL IN CF SUBJECTS WITH EXOCRINE PANCREATIC INSUFF

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项针对囊性纤维化(CF)伴胰腺外分泌功能不全(PI)患者的国际化、多中心、2期、随机、双盲TheraCLEC-Total和单盲Creon的平行剂量范围试验。这项研究计划招募总共约140名受试者，服用三种剂量的TheraCLEC-Total和一支服用Creon的受试者(每支受试者大约35名)。这项研究分为四个不同的观察和评估阶段：筛查、基线、治疗和随访。治疗期包括门诊护理和住院护理相结合。按研究期划分的评估时间表和程序载于附录1。

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 an international, multicenter, phase 2, randomized, double blind for TheraCLEC-Total and single blind for Creon, parallel, dose ranging trial in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency (PI). The study plans to enroll a total of approximately 140 subjects at three dose levels of TheraCLEC-Total and one arm of Creon (approximately 35 subjects per arm). The study is separated into four distinct periods of observation and assessment: Screening, Baseline, Treatment and Follow-up. The Treatment Period includes a combination of both outpatient care and inpatient care. The Schedule of Assessments and Procedures by Study Period is provided in Appendix 1.