Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

Inclusion Criteria:

• Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis
• Current or historical human fecal elastase < 50µg/gstool
• Weight greater than 3.75 kg
• Age 1 month to 6 years
• Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
• Clinically stable condition without evidence of acute respiratory disease or any other acute condition

Exclusion Criteria:

• Ileus or acute abdomen
• History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
• History of distal ileal obstruction syndrome within 6 months of enrollment
• Use of an immunosuppressive drug
• Any type of malignancy involving the digestive tract in the last 5 years
• Known infection with HIV