Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.

Inclusion Criteria:

• Pancreatic insufficiency (PI) documented by fecal elastase <100 mcg/gram measured at screening

• Diagnosis of CF based upon the following criteria:

  • two clinical features consistent with CF AND
  • either genotype with two identifiable mutations consistent with CF OR
  • sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis

• Forced Expiratory Volume Over One Second (FEV1) ≥30% predicted

• Clinically stable with no evidence of acute upper or lower respiratory tract infection

Exclusion Criteria:

• Pregnancy, breastfeeding or of childbearing potential and/or not willing to use accepted methods of birth control during enrollment in the study
• History of fibrosing colonopathy
• History of liver transplant or lung transplant
• Unable to discontinue enteral tube feedings during the study
• Subject weight <40 kg
• Known hypersensitivity to food additives
• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
• Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject