At a glance
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OPTION 2: A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis; With an Extension Phase Evaluation of Immediate Release MS1819 Capsules
In Brief
A Phase 2 clinical trial evaluating MS1819 and Porcine PERT for Exocrine Pancreatic Insufficiency (EPI) and Cystic Fibrosis (CF). Completed, enrolled 27 participants across 15 sites in 2 countries.
Detailed Summary
The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The exploratory objective of the extension phase (EP) is to find a dose of MS1819 in immediate release capsules that is safe and results in CFA values in a therapeutic range.
Study Details
Timeline
Interventions
MS1819 in enteric capsules. It contains is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.
Porcine PERT is being used a comparator to MS1819 as a second drug/intervention.