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

NCT06477159 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2023H0394
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• Patient-Reported EPI Symptoms - Short Term

  Determine the patient-reported change in total Exocrine Pancreatic Insufficiency (EPI) symptom score as measured by the EPI Symptom Tracker from baseline to 30 days of pancrelipase treatment; scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.

  30 days

Secondary Outcomes (11)

• Patient-Reported EPI Symptoms - LongTerm

  180 days

• Change in Stool Frequency

  180 days

• Change in Stool Consistency

  180 days

• Change in Depression Score

  180 days

• Change in SF-12 Health Score

  180 days

Other Outcomes (4)

• Frequency, Type, and Severity of Adverse Events

  210 days

• Patient-Reported EPI Symptoms - Post-Treatment

  210 days

• Change in Stool Frequency

  210 days

Study Arms (1)

Pancrelipase

EXPERIMENTAL

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)

Drug: Pancrelipase Capsules

Interventions

Pancrelipase Capsules DRUG

Treatment with Pancreatic Enzyme Replacement Therapy

Also known as: CREON

Pancrelipase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

Sponsors & Collaborators

• Ohio State University: lead
• University of Pittsburgh: collaborator
• University of Illinois Chicago: collaborator
• University of Southern California: collaborator
• New York University: collaborator
• AbbVie: collaborator

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

New York University Langone Medical Center

New York, New York, 10016, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Central Study Contacts

Zoe Krebs, BA

CONTACT

614-685-3619; zoe.krebs@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 27, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (5)