Clinical Trial: Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency
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 Summary: 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.
Sponsor: Swedish Orphan Biovitrum
Current Primary Outcome: The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA) [ Time Frame: Final 3 days of baseline and treatment period ]
The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level.
CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed).
Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period.
Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method.
The unit of CFA is %
Original Primary Outcome: Coefficient of fat absorption measured in stool collected for a 72-hour period during the final 3 days of each period [ Time Frame: Final 3 days of each 6-day treatment period ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Swedish Orphan Biovitrum
Dates:
Date Received: August 26, 2008
Date Started: August 2008
Date Completion:
Last Updated: November 17, 2014
Last Verified: November 2014
