Trials / Unknown
UnknownNCT03051490
RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Anthera Pharmaceuticals · Industry
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
Summary
Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will be comparative efficacy measured as the change from baseline in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Liprotamase | oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
| DRUG | porcine PERT | oral, enterically-coated, pig-derived, pancreatic enzyme replacement |
Timeline
- Start date
- 2017-04-28
- Primary completion
- 2018-02-28
- Completion
- 2018-06-01
- First posted
- 2017-02-13
- Last updated
- 2018-03-08
Locations
50 sites across 7 countries: United States, Hungary, Israel, Lithuania, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03051490. Inclusion in this directory is not an endorsement.