Status:
COMPLETED
Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with cystic fibrosis and pancreatic insufficiency who are able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days and are able to produce stools \>= 5 times per week
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00743483
Start Date
August 1 2008
End Date
June 1 2009
Last Update
November 18 2014
Active Locations (4)
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1
Erasmus Medical Center
Rotterdam, Netherlands
2
Specjalistyczny Zespól Opieki Zdrowotnej nad Matka i Dzieckiem w Gdansku
Gdansk, Poland
3
Uniwersytet Medyczny im. K. Marcinkowskiego
Poznan, Poland
4
Oddzialu Terenowego Instytutu, Gruzlicy i Chorob Pluc w Rabce-Zdroju
Rabka-Zdrój, Poland