Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477159
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-13
Brief Title:
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency the PERT-AP Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERT-AP
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
Detailed Description:
This is a prospective multi-center open-label single-arm study of pancrelipase CREON in eligible outpatient adults following an episode of acute pancreatitis Following study eligibility evaluation and informed consent patients will complete a 7-day run-in period without any pancreatic enzyme replacement therapy and complete baseline questionnaires and assessments followed by a 180-day treatment period with pancrelipase The study will end after a final 30 day-post pancrelipase treatment observation period during which safety events will be collected and EPI symptom burden as well as stool frequency and consistency will be assessed as primary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None