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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00743483 |
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Date of registration:
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26/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
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Scientific title:
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An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00743483 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Netherlands
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Poland
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Contacts
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Name:
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Jean-Pierre Isal, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Swedish Orphan Biovitrum |
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Name:
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Janneke Langendonk, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Erasmus Medical Center, Rotterdam, Netherlands |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Exocrine Pancreatic Insufficiency
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Intervention(s)
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Drug: rhBSSL
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Primary Outcome(s)
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The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)
[Time Frame: Final 3 days of baseline and treatment period]
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Secondary ID(s)
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2007-004063-21
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BVT.BSSL-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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