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OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis — OPTION  

Cystic Fibrosis (CF) Clinical Trial

Official title:
A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

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

Clinical Trial Details
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
View Details
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