Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
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|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|
|Primary Completion Date :||June 2009|
|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 %
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|