A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
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
Panafina, Inc.
36 participants
Jun 28, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria6
- 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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Interventions
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
Locations(15)
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NCT06080789