Actively Recruiting
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
Led by Panafina, Inc. · Updated on 2026-05-28
36
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a single dose of RABI-767 delivered by endoscopic ultrasound (EUS) guided injection near the pancreas in adults with predicted severe acute pancreatitis. This Phase 2a, randomized, open-label study compares RABI-767 plus standard care to standard care alone to better understand the treatment's impact on this serious condition. Participants are randomly assigned to receive either one injection of 125 mg RABI-767 along with standard supportive care or standard care only. The injection is given through an EUS-guided peripancreatic procedure. The study monitors participants from enrollment through follow-up visits up to 60 days, assessing outcomes related to pancreatitis severity and complications. During the study, participants will undergo various assessments including clinical chemistry, blood counts, vital signs, oxygen levels, and imaging scans. Researchers will track adverse events, organ function, inflammation scores, pain levels, hospital stay length, and mortality rates. Safety and efficacy are evaluated mainly within the first 28 to 60 days after treatment, with follow-up visits to monitor progress and complications.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute pancreatitis
- Predicted severe acute pancreatitis based on study criteria
- No meaningful improvement since hospital admission as judged by the investigator
- Suitable for endoscopic ultrasound-guided injection procedure
- Available contrast-enhanced CT or MRI of abdomen/pancreas for evaluation
You will not qualify if you...
- Confirmed severe acute pancreatitis with persistent organ failure lasting more than 48 hours
- Expected discharge from hospital within 48 hours of randomization
- More than 30% pancreatic necrosis on screening CT or MRI
- History of previous pancreatic necrosis or necrosectomy
- History of calcific chronic pancreatitis
- Evidence of cholangitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From single-dose administration up to 28 days or hospital discharge, if earlier
Participants receive a single dose of RABI-767 by endoscopic ultrasound-guided peripancreatic injection plus standard-of-care or standard-of-care alone.
Visits during hospitalization through Day 28
Duration - Up to 60 days after baseline
Participants are monitored for safety and clinical outcomes including adverse events, complications, and mortality.
Follow-up visits up to Day 60
Trial Site Locations
Total: 16 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Keck Hospital of USC and LA County Hospital
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Florida Health
Gainesville, Florida, United States, 32608
Actively Recruiting
5
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
6
UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, Illinois, United States, 60612
Actively Recruiting
7
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Withdrawn
8
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
11
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
12
Lisie Hospital
Kochi, Kerala, India, 682018
Actively Recruiting
13
Christian Medical College (CMC) Vellore, Ranipet Campus
Vellore, TamiNadu, India, 632517
Actively Recruiting
14
Postgraduate Institute of Medical Education and Research
Chandigarh, India
Not Yet Recruiting
15
All India Institute of Medical Sciences
Delhi, India, 110029
Actively Recruiting
16
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
New Delhi, India, 110002
Actively Recruiting
Research Team
K
Kelly Abernathy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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