In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
113
160,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
240,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
The commercially available pPERT Creon will be the active comparator in the study. Subjects will be instructed to take Creon according to the package insert and PI direction.
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
Time frame: From Visit 1 to Visit 5, anticipated average 80 days
Coefficient of Fat Absorption (CFA)
Mean change from baseline CFA (i.e., Period B CFA minus Period A CFA) assessed for ANG003 Dose A, ANG003 Dose B, and Creon amongst subjects with baseline CFA ≥80%.
Time frame: Period A (baseline) and Period B 72 hour CFA collection
Plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) (ug/mL)
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Time frame: Period A (baseline) and Period B time 0, 1, 2, 4, 6, 8, 10 and 24 hour collections
Coefficient of Nitrogen Absorption (CNA)
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Time frame: Period A (baseline) and Period B 72 hour CNA collection
% of subjects with GI symptoms
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Time frame: From Visit 2 to Visit 5, anticipated average 59 days
Cumulative stool weight
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Time frame: Period A (baseline) and Period B 72 hour collection
Number of Stools per Day
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Long Beach Memorial Medical Center
Long Beach, California, United States
RECRUITINGCenter for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, United States
RECRUITINGNational Jewish Health
Denver, Colorado, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
NOT_YET_RECRUITINGCentral Florida Pulmonary Group
Orlando, Florida, United States
NOT_YET_RECRUITINGThe Cystic Fibrosis Institute
Glenview, Illinois, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
NOT_YET_RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGUniversity of Kentucky
Lexington, Kentucky, United States
RECRUITINGMaineHealth Pediatric Specialty Care
Portland, Maine, United States
NOT_YET_RECRUITING...and 17 more locations
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Time frame: Period A (baseline) and Period B 72 hour collection