ORAL THERACLECTM-TOTAL IN CYSTIC FIBROSIS SUBJECTS WITH PANCREATIC INSUFFICIENCY

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、随机、双盲的theraclecl - total和单盲的Creon，口服theraclecl - total平行剂量范围研究，用于囊性纤维化（CF）伴有外分泌胰腺功能不全（PI）的受试者。这项2期研究将测试theraclecc -Total的安全性和疗效终点（脂肪酶[主要终点]，蛋白酶和淀粉酶[次要终点]）。我们将研究三种剂量的theraclecl - total，试图确定最低有效剂量，从而优化3期研究药物剂量的选择。作为次要目标，theraclecl - total将与活性比较剂Creon¿进行比较。在80名患者完成随机治疗期后，将进行中期分析。

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, randomized, double blind for TheraCLEC-Total and single blind for Creon, parallel dose ranging study of oral TheraCLEC-Total in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency (PI). This Phase 2 study will test the safety of TheraCLEC¿-Total and efficacy endpoints for each of TheraCLEC-Total¿s active components (lipase [primary endpoint], protease and amylase [secondary endpoints]). Three doses of TheraCLEC-Total will be studied in an attempt to identify the lowest effective dose, thereby optimizing the choice of study drug dose in Phase 3. As a secondary objective, TheraCLEC-Total will be compared to the active comparator, Creon¿. An interim analysis will be performed after 80 patients complete the randomized Treatment Period.