A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
- Registration Number
- NCT06080789
- Lead Sponsor
- Panafina, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RABI-767 plus Standard-of-Care RABI-767 Single-dose 125 mg RABI-767 plus standard-of-care
- Primary Outcome Measures
Name Time Method Change from Baseline in Hematology Parameters Baseline to Day 7 Number of Participants with Serious Adverse Events Enrollment/Randomization to Day 35 Follow-up A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.
Change from Baseline in Vital Signs Baseline to Day 7 Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements Baseline to Day 7 Number of Participants with Adverse Events Enrollment/Randomization to Day 28 (or hospital discharge, if earlier) 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.
Change from Baseline in Clinical Chemistry Parameters Baseline to Day 7
- Secondary Outcome Measures
Name Time Method Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis From Baseline through Day 60 Follow-up Development of New Onset Moderately Severe Acute Pancreatitis Day 1 to Day 28 (or hospital discharge, if earlier) Defined as transient organ failure and/or local or systemic complications without persistent organ failure
Development of Pancreatic Necrosis Baseline to Day 60 Follow-up As identified on CECT/CEMRI imaging; may be further sub-grouped into \<30%, 30%-50%, and \>50% pancreatic necrosis, if data allow.
Development of Local Complications of Acute Pancreatitis Baseline to Day 60 Follow-up As identified on CECT/CEMRI imaging; may be further sub-grouped by type of complication, if data allow.
Days in Hospital Day 1 through Day 28 (or hospital discharge, if earlier) Development of New Onset Infection Day 1 to Day 28 (or hospital discharge, if earlier) May be further sub-grouped by: pancreatic, peripancreatic, and extra-pancreatic infections, as data allow.
Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment From Baseline through Day 28 (or hospital discharge, if earlier) Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis Day 1 to Day 60 Follow-up Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis
Length of Stay in Intensive Care Unit Day 1 through Day 28 (or hospital discharge, if earlier) Change in Modified Marshall Score From Baseline through Day 28 (or hospital discharge, if earlier) Re-hospitalization for acute pancreatitis or related complications From initial hospital discharge to Day 35 Follow-up Number of participants re-hospitalized for acute pancreatitis or related complications out of total participants who are discharged.
Change in Sequential Organ Failure Assessment (SOFA) Score From Baseline through Day 28 (or hospital discharge, if earlier) Change in Abdominal Pain Numeric Rating Score From Baseline through Day 28 (or hospital discharge, if earlier) Development of Severe Acute Pancreatitis Day 1 to Day 28 (or hospital discharge, if earlier) Defined as \>48 hours persistent organ failure
Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis From Baseline through Day 60 Follow-up Mortality due to any cause Day 1 to Day 60 Follow-up Death due to any cause
Trial Locations
- Locations (10)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
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 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
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States