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

Recruiting now · Phase 4

Conditions studied: Exocrine Pancreatic Insufficiency

In brief

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.

Key facts

Study ID

NCT06477159

Run by

Ohio State University

People needed

30

Starts

2024-02-01

Expected to finish

2027-12-31

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
• 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).
• Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
• Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
• Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).
• Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).
• 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.
• 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.
• OR
• Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
• do not require pregnancy testing.

You may not qualify if…

• Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
• History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
• Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
• Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
• Gastroparesis.
• 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).
• Prior pancreatic surgery or GI tract surgery affecting the upper GI tract including but not limited to gastric bypass surgery, total pancreatectomy.
• Pregnancy or breast feeding.
• 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.
• Incarcerated individuals

Where it is running

• University of Southern California — Los Angeles, California, United States (enrolling)
• University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States
• New York University Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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