Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
|ClinicalTrials.gov Identifier: NCT00743483|
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Exocrine Pancreatic Insufficiency||Drug: rhBSSL||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
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
- 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 %
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|