Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
NCT ID: NCT06477159
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-02-01
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pancrelipase
Pancrelipase (CREON) capsules taken orally with food, at a dose 36,000 units with snacks and 72,000 units with meals, for a total of 6 months (180 days)
Pancrelipase Capsules
Treatment with Pancreatic Enzyme Replacement Therapy
Interventions
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Pancrelipase Capsules
Treatment with Pancreatic Enzyme Replacement Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
OR
* Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
do not require pregnancy testing.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
University of Illinois Chicago
UNKNOWN
University of Southern California
OTHER
New York University
OTHER
AbbVie
INDUSTRY
Ohio State University
OTHER
Responsible Party
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Locations
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University of Southern California
Los Angeles, California, United States
University of Illinois Chicago
Chicago, Illinois, United States
New York University Langone Medical Center
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023H0394
Identifier Type: -
Identifier Source: org_study_id
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