A Phase 2a, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 Administered by Endoscopic Ultrasound-Guided Peripancreatic Injection Plus Standard-of-Care Versus Standard-of-Care Only in Participants With Predicted Severe Acute Pancreatitis
J
John DeWitt, MD
Primary Investigator
Enrolling By Invitation
18 years - 85 years
All
Phase
2
3 participants needed
1 Location
Brief description of study
What is the goal of this study?
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.
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
What will happen during the study?
- 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute pancreatitis
-
Age: 18 years - 85 years
-
Gender: All
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 contrast-enhanced magnetic resonance imaging (CEMRI) 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
- Pancreatic necrosis on screening CECT or CEMRI
- History of previous pancreatic necrosis, including necrosectomy
- History of calcific chronic pancreatitis
- Evidence of cholangitis
Updated on
07 May 2025.
Study ID: ECRO-PANAFINA-RABI-767, 26987
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