At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
MS1819 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating MS1819 and Porcine PERT for Exocrine Pancreatic Insufficiency (EPI) and Cystic Fibrosis (CF). Completed, enrolled 41 participants across 14 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartJan 2019
Primary CompletionJul 2019
Study CompletionJul 2019
TodayJul 2026
First PostedNov 19, 2018
Enrollment StartJan 10, 2019
Primary CompletionJul 13, 2019
Study CompletionJul 27, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.6 years ago
Interventions
MS1819drug
MS1819, an oral, non-systemic, that is non-enterically-coated. It is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.
Porcine PERTdrug
Porcine PERT is being used as a comparator to MS1819 as a second drug/intervention