Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)

Inclusion Criteria

• •Participants or their legally authorized representative must understand the nature of the study and sign an informed consent or assent form along with a parental form
• •Participants must have a confirmed diagnosis of CF based on 1 or more clinical features consistent with the CF phenotype, and one of the following:
• •* A genotype with 2 identifiable mutations consistent with CF
• •* A sweat chloride test greater than 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis
• •Participants must have PI as demonstrated by a fecal elastase-1 (FE-1) concentration less than 100 microgram per gram (mcg/g) of stools (ScheBo test) and must require pancreatic enzyme supplementation
• •Participants must be clinically stable as evidenced by medical and medication history, baseline physical examination including vital signs and laboratory analyses
• •Participants must be 7 years and older
• •Participants must have an adequate nutritional status based on the following body mass index (BMI):
• •* Participants 7 to 20 years old must have a BMI greater than or equal to fifth percentile
• •* Female participants greater than 20 years old must have a BMI greater than or equal to 16
• •* Male participants greater 20 years old must have a BMI greater than or equal to 16.5
• •Participants must be on an optimal clinical dose of pancreatic enzymes (Ultrase® MT18 or MT20 or other pancreatic enzymes preparations including Ultrase® MT12) prior to entry in the study, and must tolerate this medication in the opinion of the investigator
• •Participants must be able to swallow capsules and must be able to eat a high fat diet calculated as 2 gram (± 15%) fat per kilogram body weight per day
• •Participants must be, in the opinion of the investigator, able and willing to complete this study
• •Female participants must be premenarcheal, surgically sterile or postmenopausal for at least 12 consecutive months. Otherwise, the women of childbearing potential (WOCBP) must not be pregnant and must have practiced an acceptable method of contraception for at least one month prior to the study entry