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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Investigator Site 114
Aurora, Colorado, United States
Investigator Site 134
Jackson, Mississippi, United States
Investigator Site 121
Burlington, Vermont, United States
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
Descriptive analysis
Time frame: 12 months
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Investigator Site 501
Brno, Czechia
Investigator Site 303
Debrecen, Hajdú-Bihar, Hungary
Investigator Site 302
Törökbálint, Pest County, Hungary
Investigator Site 304
Mosdós, Somogy County, Hungary
Investigator Site 301
Ajka, Veszprém megye, Hungary
Investigator Site 601
Jerusalem, Israel
Investigator Site 203
Karpacz, Poland
...and 5 more locations