EASY: Extended Access to Sollpura Over Years
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 5/19/2018 |
| Start Date: | September 2016 |
| End Date: | March 2018 |
An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
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.
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.
The purpose of the present study is to evaluate the safety of long-term use of liprotamase in
the management of cystic fibrosis-related exocrine pancreatic insufficiency
the management of cystic fibrosis-related exocrine pancreatic insufficiency
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.
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