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

Study acronym: PERT-AP
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment target: 60 to 30v6 Show 5 more changesShow less
    • Primary completion date: Dec 31, 2026 to Sep 30, 2027
    • Study sites: 5 to 6
    • Study completion date: Jul 31, 2027 to Dec 31, 2027
    • Secondary endpoints: details revised at 1 of 11 entries
    • Collaborators: 5 to 6
  2. Re-verified, no change to tracked fieldsv5
  3. Site details revised at 4 of 5 sitesv4
  4. Site contacts updated at 2 of 5 sitesv3
  5. Secondary endpoints: 7 to 11v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06477159
Lead Sponsor Ohio State University
Collaborators: University of Pittsburgh, University of Illinois at Chicago, University of Southern California, New York University, AbbVie, University of Minnesota
Conditions
(from sponsor)		 Exocrine Pancreatic Insufficiency
Related terms Exocrine Pancreatic Insufficiency
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov