Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency|
- The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA) [ Time Frame: Final 3 days of baseline and treatment period ] [ Designated as safety issue: No ]
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 %
|Study Start Date:||August 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
170 mg rhBSSL three times daily for 5 to 6 consecutive days
oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
Other Name: BSSL, Bucelipase alfa, rhBSSL
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743483
|Erasmus Medical Center|
|Specjalistyczny Zespól Opieki Zdrowotnej nad Matka i Dzieckiem w Gdansku|
|Uniwersytet Medyczny im. K. Marcinkowskiego|
|Oddzialu Terenowego Instytutu, Gruzlicy i Chorob Pluc w Rabce-Zdroju|
|Study Director:||Jean-Pierre Isal, MD, PhD||Swedish Orphan Biovitrum|
|Principal Investigator:||Janneke Langendonk, MD, PhD||Erasmus Medical Center, Rotterdam, Netherlands|