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NCT02279498 · ClinicalTrials.gov registry record · Phase 3
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
A Phase 3 study, sponsored by Anthera Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 128
- Enrollment target
NCT02279498: Completed Phase 3 study, sponsored by Anthera Pharmaceuticals.
NCT02279498 is a Phase 3 study that has completed, run by Anthera Pharmaceuticals. The registered enrollment target is 128 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02279498, a Phase 3 study, has completed, sponsored by Anthera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 128 participants
- Enrollment target
Study Summary
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI). Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.
Primary Outcome
The primary endpoint evaluates the difference between treatment arms in change from baseline in coefficient of fat absorption (CFA). As such, descriptive statistics for individual treatment arms are not provided in this measure, but are reported in the secondary endpoints
Interventions
- DRUG Liprotamase
- DRUG porcine (pig) PERT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-01-20 |
| Phase | Phase 3 |
What the finished NCT02279498 record still lists
NCT02279498 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Liprotamase is the first listed.
NCT02279498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02279498 about?
NCT02279498 is a clinical study titled "SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis". Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic...
What is the current status of trial NCT02279498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 128 participants. The study started on 2015-06. Estimated completion is 2017-01-20.
What interventions are being tested in trial NCT02279498?
The interventions under investigation include: Liprotamase (DRUG), porcine (pig) PERT (DRUG).
Who is sponsoring clinical trial NCT02279498?
This trial is sponsored by Anthera Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02279498's enrollment target sits among peer trials
128 1601st of 2000 higher than 399 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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