NCT00743483

Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency

An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	rhBSSL	oral suspension, 170 mg BSSL, 3 times daily for 5-6 days

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-08-28
• Last updated: 2014-11-18
• Results posted: 2014-11-18

Locations

4 sites across 2 countries: Netherlands, Poland