Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Exclusion Criteria

• •CFA \>80% at Baseline
• •Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
• •History of fibrosing colonopathy
• •History of liver transplant, lung transplant or significant surgical resection of the bowel
• •Any acute or chronic diarrheal illness unrelated to PI
• •Unable to discontinue enteral tube feedings during the study
• •Known hypersensitivity to food additives
• •Inability to consume the diet required by the study, in the judgment of the Investigator
• •Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
• •Abnormal liver function (except for patients with Gilbert Syndrome)
• •Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF
• •Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening
• •Unable to discontinue the use of pancreatic enzymes
• •Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
• •Patient is unlikely to complete the study, as determined by the Investigator