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A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis

RecruitingPhase 2Ages 18 Years - 85 YearsAllPanafina, Inc.
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In plain words

What the trial is, and whether it could suit you

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: โ€ข 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: โ€ข 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 o

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • RABI-767
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Where

16 sites
University of Arkansas for Medical Sciences
Little Rock, United States
Keck Hospital of USC and LA County Hospital
Los Angeles, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
University of Florida Health
Gainesville, United States
Orlando Health
Orlando, United States
UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, United States
Indiana University Health University Hospital
Indianapolis, United States
Johns Hopkins Hospital
Baltimore, United States

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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