drugset / Trial / NCT03746483

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

NCT03746483 ↗

Phase 2 Completed 41 enrolled Entero Therapeutics
RandomizedCrossoverOpen-labelTreatment

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).

Timeline

Start
2019-01-10
Primary completion
2019-07-13
Completion
2019-07-27

Drugs

EvaluationDrugModalityDoseRoute
Subject MS1819 Protein / enzyme biologic 2240 mg Oral