RECRUITING

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

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Conditions

Exocrine Pancreatic Insufficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency: the PERT-AP Trial

Quick Facts

Study Start:2024-02-01
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06477159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
  2. 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. 3. Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
  4. 4. Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
  5. 5. Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).
  6. 6. Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).
  7. 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. 8. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile as defined:
  9. * Age \> 55 years with no menses for 12 or more months without an alternative medical cause.
  10. * Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level \> 40 IU/L.
  11. * Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  1. 1. Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
  2. 2. History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
  3. 3. Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
  4. 4. Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
  5. 5. Gastroparesis.
  6. 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. 7. Prior pancreatic surgery or GI tract surgery affecting the upper GI tract including but not limited to gastric bypass surgery, total pancreatectomy.
  8. 8. Pregnancy or breast feeding.
  9. 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. 10. Incarcerated individuals

Contacts and Locations

Study Contact

Zoe Krebs, BA
CONTACT
614-685-3619
zoe.krebs@osumc.edu

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
University of Illinois Chicago
Chicago, Illinois, 60612
United States
New York University Langone Medical Center
New York, New York, 10016
United States
The Ohio State University
Columbus, Ohio, 43210
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Exocrine Pancreatic Insufficiency