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Clinical Trial Summary

The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).


Clinical Trial Description

This is a Phase 2, open-label, multi-center, 2x2 crossover study assessing the safety and efficacy of MS1819-SD (spray dried) vs porcine PERT given at the same dose that was being administered during the pre-study period. MS1819-SD will be assessed in a 2x2 crossover including at least 30 patients completing both periods. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03746483
Study type Interventional
Source First Wave Bio, Inc.
Contact
Status Completed
Phase Phase 2
Start date January 10, 2019
Completion date July 27, 2019

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