A Phase 3 Randomized Open-Label Assessor-Blind Non-Inferiority Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
C
Cynthia Brown, MD
Primary Investigator
J
Jessica MacLean
Primary Investigator
Not Recruiting
100 years or below
All
Phase
N/A
1 Location
Brief description of study
The purpose of this study is to demonstrate the non-inferiority of liprotamase to the active comparator for the change in coefficient of fat absorption from screening to the end of the treatment period in subjects > or = 7 years of age with EPI due to cystic fibrosis.
Detailed description of study
The purpose of this study is to demonstrate the non-inferiority of liprotamase to the active comparator for the change in coefficient of fat absorption from screening to the end of the treatment period in subjects > or = 7 years of age with EPI due to cystic fibrosis.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: cystic fibrosis
-
Age: 100 years or below
-
Gender: All
Updated on
01 Aug 2024.
Study ID: 1510435361
