Status:
RECRUITING
A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
Lead Sponsor:
Panafina, Inc.
Conditions:
Acute Pancreatitis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic injection in participants with predicted...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of acute pancreatitis
- Predicted severe acute pancreatitis, based on protocol defined criteria
- Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization
- Suitable for EUS-guided study drug administration procedure
- Contrast-enhanced computed tomography (CECT) or magnetic resonance imaging (MRI) of the abdomen/pancreas available for the evaluation of exclusion criteria
- Key
Exclusion
- Confirmed severe acute pancreatitis as defined by the Revised Atlanta Classification of Acute Pancreatitis (ie, Persistent \[\> 48 hours\] organ failure, per Modified Marshall Score), prior to randomization
- Anticipated discharge from hospital within 48 hours of randomization
- More than 30% pancreatic necrosis on screening CECT or MRI
- History of previous pancreatic necrosis, including necrosectomy
- History of calcific chronic pancreatitis
- Evidence of cholangitis
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06080789
Start Date
June 28 2024
End Date
June 1 2026
Last Update
December 24 2025
Active Locations (14)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Keck Hospital of USC and LA County Hospital
Los Angeles, California, United States, 90033
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
4
University of Florida Health
Gainesville, Florida, United States, 32608