Phase 4
Completed N=25
EASY: Extended Access to Sollpura Over Years
Source: ClinicalTrials.gov NCT02823964 ↗Enrolled (actual)
25
Serious AEs
12.0%
Results posted
May 2018
Primary outcomePrimary: Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities — 25; 9 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities |
25; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)
Exclusion Criteria
- Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
- Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.
Data sourced from ClinicalTrials.gov (NCT02823964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.