ORAL THERACLECTM-TOTAL IN CYSTIC FIBROSIS SUBJECTS WITH PANCREATIC INSUFFICIENCY

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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.