drugset / Trial / NCT06477159
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
Phase 4
Recruiting
30 enrolled
Ohio State University
AbbVie · collabNew York University · collabUniversity of Illinois at Chicago · collabUniversity of Minnesota · collabUniversity of Pittsburgh · collabUniversity of Southern California · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-02-01
- Primary completion
- 2027-09-30
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pancrelipase | Protein / enzyme biologic | 36000 iu | Oral |
| Subject | Pancrelipase | Protein / enzyme biologic | 72000 iu | Oral |