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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项国际、多中心、2期、随机、双盲（theraclecl - total）和单盲（Creon）、平行、剂量范围试验，用于囊性纤维化（CF）伴有外分泌性胰腺功能不全（PI）的受试者。该研究计划共招募约140名受试者，使用三个剂量水平的theraclecc - total和一支Creon（每支约35名受试者）。该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。治疗期包括门诊治疗和住院治疗的结合。按研究期间划分的评估和程序时间表载于附录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.