A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
NCT ID: NCT06080789
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-06-28
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RABI-767 plus Standard-of-Care
Single-dose 125 mg RABI-767 plus standard-of-care
RABI-767
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
Standard-of-Care Only
No Intervention, Standard-of-Care Only
No interventions assigned to this group
Interventions
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RABI-767
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Panafina, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Role: backup
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Clinical Research Coordinator
Role: primary
Other Identifiers
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RABI-767-201
Identifier Type: -
Identifier Source: org_study_id