Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency: the PERT-AP Trial
Ohio State University
Summary
This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of \<200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.
Description
This is a prospective, multi-center, open-label, single-arm study of pancrelipase (CREON) in eligible outpatient adults following an episode of acute pancreatitis. Following study eligibility evaluation and informed consent, patients will complete a 7-day run-in period without any pancreatic enzyme replacement therapy and complete baseline questionnaires and assessments, followed by a 180-day treatment period with pancrelipase. The study will end after a final 30 day-post pancrelipase treatment observation period during which safety events will be collected, and EPI symptom burden as well as s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult patients of age 18 or older, able to provide informed consent and follow all study procedures. 2. Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 \< 200 µg/g stool obtained within 3 months prior to baseline assessment (Visit 2). 3. Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2. 4. Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2. 5. Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical…
Interventions
- DrugPancrelipase Capsules
Treatment with Pancreatic Enzyme Replacement Therapy
Locations (5)
- University of Southern CaliforniaLos Angeles, California
- University of Illinois ChicagoChicago, Illinois
- New York University Langone Medical CenterNew York, New York
- The Ohio State UniversityColumbus, Ohio
- University of PittsburghPittsburgh, Pennsylvania