Actively Recruiting
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
Led by Ohio State University · Updated on 2025-10-22
60
Participants Needed
5
Research Sites
182 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
U
University of Pittsburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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).
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Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
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Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
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Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).
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Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).
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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.
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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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
3
New York University Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
5
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
Z
Zoe Krebs, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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