Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
NCT Number: NCT06477159
Acronym: PERT-AP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Exocrine Pancreatic Insufficiency
Interventions: DRUG: Pancrelipase Capsules
Sponsor: Ohio State University
Collaborators: University of Pittsburgh|University of Illinois Chicago|University of Southern California|New York University|AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2027-07-31
Locations: 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

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.

Primary Outcome Measures: 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 Outcome Measures: Patient-Reported EPI Symptoms - LongTerm, Determine the patient-reported change in total Exocrine Pancreatic Insufficiency (EPI)symptom score as measured by the EPI Symptom Tracker from baseline to the end of pancrelipase treatment (180 days); scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms., 180 days|Change in Stool Frequency, Record changes in stool frequency from baseline to 30 days and from baseline to the end of pancrelipase treatment (180 days), 180 days|Change in Stool Consistency, Record change in stool consistency from baseline to 30 days and from baseline to the end of pancrelipase treatment, 180 days|Change in Depression Score, Change in depression score assessed by the Patient Health Questionnaire (PHQ-9) from baseline to 30 days and from baseline to end of pancrelipase treatment; scores range from 0 - 27, with a higher score meaning worse depression symptoms, 180 days|Change in SF-12 Health Score, Change in self-assessment of health status as assessed by the 12-Item Short Form Survey (SF-12) from baseline to 30 days and from baseline to end of pancrelipase treatment (180 days); form is not numerically scored, 180 days|Change in Global Health Score, Change in Global Health score assessed by the Global Health (PROMIS) Questionnaire. Each question is scored 1 - 5, with high values indicating better health status in the first part of the form, and high values indicating poor health status in the latter part of the form; also included is a 0-10 average pain scale., 180 days|Medication Adherence, Medication adherence assessed by pill count and the Morisky Medication Adherence Scale (MMAS-8) from baseline to 30 days of pancrelipase treatment and from 30 days to end of pancrelipase treatment (180 days); A score below 6 indicates low adherence, and a score of 8 high adherence. Scale ranges from 0 - 8., 180 days|Change in Nutrition Biomarkers - Vitamin D, Change in serum nutrition biomarker Vitamin D (ng/mL), 180 days|Change in Nutrition Biomarkers - Retinol Binding Protein, Change in serum nutrition biomarker Retinol Binding Protein (mg/dL), 180 days|Change in Nutrition Biomarkers - Pre-albumin, Change in serum nutrition biomarker Pre-albumin (mg/dL), 180 days|Change in Nutrition Biomarkers - Albumin, Change in serum nutrition biomarker Albumin (g/dL), 180 days
Other Outcome Measures: Frequency, Type, and Severity of Adverse Events, Evaluate the frequency, severity, and causality of adverse events (AEs), treatment emergent AEs (TEAEs), and serious AEs (SAEs); Descriptive assessment of safety and tolerability using FAS set with AEs collected from time of consent to 30 days after end of pancrelipase treatment, 210 days|Patient-Reported EPI Symptoms - Post-Treatment, Change in total Exocrine Pancreatic Insufficiency (EPI) symptom score as measured by the EPI Symptom Tracker from end of pancrelipase treatment to end of 30-day follow-up period; scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms., 210 days|Change in Stool Frequency, Change in stool frequency from end of pancrelipase treatment to end of 30-day follow-up period, 210 days|Change in Stool Consistency, Change in stool consistency from end of pancrelipase treatment to end of 30-day follow-up period, 210 days