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Nutritional-GI Closed to Enrollment
OPTION 2: Study of AzurRX MS1819 in enteric capsules in adults with cystic fibrosis and exocrine pancreatic insufficiency (AzurRX AZ-CF2002)
This study will look at the safety and effectiveness of the drug MS1819 in enteric capsules as a pancreatic enzyme replacement therapy (PERT).
MS1819 in enteric capsules is a non-porcine (not pig-derived) enzyme that is enclosed in a capsule that has an enteric, or acid-resistant, coating to prevent it from dissolving too rapidly in the body. All participants will take the study drug in one part of the study and porcine (pig-derived) enzymes in another part. Multiple doses of MS1819 in enteric capsules will be tested to find the optimal dose. Researchers will measure the safety and effectiveness of MS1819 in enteric capsules compared to traditional pig-derived PERT by monitoring for adverse events and by measuring fat absorption. They will also measure stool weights and monitor for signs and symptoms of malabsorption.
Eligibility
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
8 weeks -
Number of Study Visits:
10
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Entero Therapeutics (Formerly AzurRx BioPharma, Inc and First Wave) -
Study Drugs:
Study Sites
-
Closed to Enrollment
California
Long Beach Memorial Medical Center, Long Beach, CA 90806
-
Closed to Enrollment
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
-
Closed to Enrollment
Florida
University of Miami, Miami, FL 33136
-
Closed to Enrollment
Illinois
CF Center Chicago (Glenview, Il), Glenview, IL 60025
-
Closed to Enrollment
Kansas
Ascension Via Christi, Saint Francis Campus, Wichita, KS 67214
-
Closed to Enrollment
Maine
Maine Medical Center, Portland, ME 04102
-
Closed to Enrollment
Nevada
Adult Cystic Fibrosis Center of Southern Nevada, Las Vegas, NV 89109
-
Closed to Enrollment
Ohio
Northwest Ohio Cystic Fibrosis Center, Toledo, OH 43606
-
Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
-
Closed to Enrollment
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
Eligibility
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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