CLINICAL TRIAL: ALTU- 135 TREATMENT IN PATIENTS WITH CF-RELATED EXOCRINE PANCREA

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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. Cystic fibrosis (CF) is a recessive genetic disease that affects approximately 30,000 children and adults in the United States. Despite progress in the treatment of CF, there is no cure. The predicted median approximate age of survival for a person with CF is the mid-30s. The study subject population of this study is Male and female with CF, 7 years of age or older, with documented exocrine Pancreatic Insufficieny (PI). The primary study objective is to demonstrate and confirm the efficacy of ALTU-135 for the treatment of fat malabsorption in patients with CF. The secondary efficacy objectives include efficacy measures of the protease and amylase components of ALTU-135, as well as determination of stool weight and frequency over the marker-to-marker stool collection periods as a clinical measure of the effect of ALTU-135 treatment on malabsorption. The tolerability and safety of ALTU-135 over the duration of the study will also be assessed. This is a Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study.