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

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。这是一项在胰腺外分泌功能不全（PI）的囊性纤维化（CF）受试者中进行的国际、多中心、II期、随机化、TheraCLEC-Total双盲和Creon单盲、平行、剂量范围探索试验。本研究计划在3个剂量水平的TheraCLEC-Total和1个Creon组共入组约140例受试者（每组约35例受试者）。研究分为四个不同的观察和评估阶段：筛选、基线、治疗和随访。治疗期包括门诊护理和住院护理的组合。按研究阶段列出的评估和程序时间表见附录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.