Conditions: Cystic Fibrosis Exocrine Pancreatic Insufficiency
Keywords: cystic fibrosis pancreatic insufficiency bucelipase alfa bile salt stimulating lipase BSSL coefficient of fat absorption
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

Detailed description:
In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be made by collecting stool during the last three days of each period.

Arms:
arm 1: 170 mg rhBSSL three times daily for 5 to 6 consecutive days

Interventions: intervention 1: rhBSSL
Intervention descriptions: intervention 1: oral suspension, 170 mg BSSL, 3 times daily for 5-6 days

Protocol document: