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A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
Sponsor: Panafina, Inc.
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 severe acute pancreatitis. The main question the study aims to answer is: • Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection safe in patients with predicted severe acute pancreatitis. The study also aims to answer: • Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis. Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only. The study sponsor will compare safety and efficacy data collected from participants who receive RABI-767 to participants who receive supportive care only to test if RABI-767 is safe and effective.
Official title: A Phase 2a, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 Administered by Endoscopic Ultrasound-Guided Peripancreatic Injection Plus Standard-of-Care Versus Standard-of-Care Only in Participants With Predicted Severe Acute Pancreatitis
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2024-06-28
Completion Date
2026-11
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
RABI-767
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
Locations (15)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Keck Hospital of USC and LA County Hospital
Los Angeles, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Florida Health
Gainesville, Florida, United States
Orlando Health
Orlando, Florida, United States
UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
NYU Langone Medical Center
New York, New York, United States
Lisie Hospital
Kochi, Kerala, India
Christian Medical College (CMC) Vellore, Ranipet Campus
Vellore, TamiNadu, India
All India Institute of Medical Sciences
Delhi, India
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
New Delhi, India