A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
Panafina, Inc. · NCT06080789
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–85 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 36
- US sites recruiting
- 10
- Study start
- June 28, 2024
- Record last updated
- August 5, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: RABI-767
Conditions: Acute Pancreatitis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key Inclusion Criteria
- 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 Criteria
- 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
Recruiting US locations
University of Arkansas for Medical Sciences
Little Rock, AR 72205
Site contact: Clinical Research Coordinator · 501-526-4860
Keck Hospital of USC and LA County Hospital
Los Angeles, CA 90033
Site contact: Clinical Research Coordinator
University of Colorado Anschutz Medical Campus
Aurora, CO 80045
Site contact: Clinical Research Coordinator · 303-724-1871
University of Florida Health
Gainesville, FL 32608
Site contact: Clinical Research Coordinator · 352-273-9483
Orlando Health
Orlando, FL 32806
Site contact: Clinical Research Coordinator · 321-841-6649
UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, IL 60612
Site contact: Clinical Research Coordinator · 630-518-5456
Johns Hopkins Hospital
Baltimore, MD 21287
Site contact: Clinical Research Coordinator · 410-614-6708
Henry Ford Hospital
Detroit, MI 48202
Site contact: Clinical Research Coordinator · 313-746-8215
Dartmouth Hitchcock Medical Center
Lebanon, NH 03756
Site contact: Clinical Research Coordinator · 603-653-3651
NYU Langone Medical Center
New York, NY 10016
Site contact: Clinical Research Coordinator · 212-263-3095
Study contacts (from the official record)
- Kelly Abernathy · 9194609500 · kabernathy@arrivobio.com