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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGKeck Hospital of USC and LA County Hospital
Los Angeles, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGUniversity of Florida Health
Gainesville, Florida, United States
RECRUITINGOrlando Health
Orlando, Florida, United States
RECRUITINGUI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, Illinois, United States
RECRUITINGIndiana University Health University Hospital
Indianapolis, Indiana, United States
WITHDRAWNJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
RECRUITINGDartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITING...and 4 more locations
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the study intervention, regardless of its causal relationship to the study intervention. For the purposes of this study, any AE occurring in any study participant (regardless of treatment group assignment) at any time after enrollment/randomization, even if no study intervention has been administered, will be recorded.
Time frame: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)
Number of Participants with Serious Adverse Events
A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.
Time frame: Enrollment/Randomization to Day 35 Follow-up
Change from Baseline in Clinical Chemistry Parameters
Time frame: Baseline to Day 7
Change from Baseline in Hematology Parameters
Time frame: Baseline to Day 7
Change from Baseline in Vital Signs
Time frame: Baseline to Day 7
Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
Time frame: Baseline to Day 7
Development of Severe Acute Pancreatitis
Defined as \>48 hours persistent organ failure
Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Development of New Onset Moderately Severe Acute Pancreatitis
Defined as transient organ failure and/or local or systemic complications without persistent organ failure
Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Development of Pancreatic Necrosis
As identified on CECT/CEMRI imaging; may be further sub-grouped into \<30%, 30%-50%, and \>50% pancreatic necrosis, if data allow.
Time frame: Baseline to Day 60 Follow-up
Development of Local Complications of Acute Pancreatitis
As identified on CECT/CEMRI imaging; may be further sub-grouped by type of complication, if data allow.
Time frame: Baseline to Day 60 Follow-up
Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis
Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis
Time frame: Day 1 to Day 60 Follow-up
Mortality due to any cause
Death due to any cause
Time frame: Day 1 to Day 60 Follow-up
Days in Hospital
Time frame: Day 1 through Day 28 (or hospital discharge, if earlier)
Re-hospitalization for acute pancreatitis or related complications
Number of participants re-hospitalized for acute pancreatitis or related complications out of total participants who are discharged.
Time frame: From initial hospital discharge to Day 35 Follow-up
Length of Stay in Intensive Care Unit
Time frame: Day 1 through Day 28 (or hospital discharge, if earlier)
Development of New Onset Infection
May be further sub-grouped by: pancreatic, peripancreatic, and extra-pancreatic infections, as data allow.
Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Change in Modified Marshall Score
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Sequential Organ Failure Assessment (SOFA) Score
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Abdominal Pain Numeric Rating Score
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis
Time frame: From Baseline through Day 60 Follow-up
Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis
Time frame: From Baseline through Day 60 Follow-up
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