Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency

Eligibility 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 or endoscopic necrosectomy or percutaneous drainage).
• 6. Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).
• 7. Women of childbearing potential must have a negative urine pregnancy test at Study Day 1 and practicing at least one protocol specified method of birth control (Section 5.2.4), starting at Study Day 1 through 30 days after last dose of pancrelipase.
• 8. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile as defined:
• * Age \> 55 years with no menses for 12 or more months without an alternative medical cause.
• * Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level \> 40 IU/L.
• * Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
• 1. Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
• 2. History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
• 3. Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
• 4. Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
• 5. Gastroparesis.
• 6. Confirmed or suspected cystic tumor associated with main pancreatic duct dilation or believed to be the cause of AP (in the site-PI's judgment).
• 7. Prior pancreatic surgery or GI tract surgery affecting the upper GI tract including but not limited to gastric bypass surgery, total pancreatectomy.
• 8. Pregnancy or breast feeding.
• 9. Patients with life expectancy of less than 6 months due to advanced chronic conditions, such as congestive heart failure or chronic obstructive pulmonary disease, or other conditions which preclude study participation by judgement of the investigator.
• 10. Incarcerated individuals