At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 25 enrolled
Drug / intervention
Liprotamasedrug
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.
An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
In Brief
A Phase 4 clinical trial evaluating Liprotamase for Exocrine Pancreatic Insufficiency and Cystic Fibrosis. Completed, enrolled 25 participants across 15 sites in 6 countries.
Detailed Summary
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExocrine Pancreatic Insufficiency, Cystic Fibrosis
CountriesCzechia, Hungary, Israel, Poland, Spain, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartSep 2016
Primary CompletionMar 2018
TodayJul 2026
First PostedJul 6, 2016
Enrollment StartSep 1, 2016
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.0 years ago
Interventions
Liprotamasedrug
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement