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
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- STATUS
- Not Recruiting
Summary
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.
Description
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.
Details
| Condition | cystic fibrosis |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX5670 |
| Last Modified on | 19 February 2024 |
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