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

Launched by PANAFINA, INC. · Oct 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RABI-767 for patients with acute pancreatitis, a serious condition that affects the pancreas. The main goal is to see if a single dose of RABI-767, which is given through a special procedure called endoscopic ultrasound, is safe and effective for those who are likely to have severe symptoms. Participants in the study will either receive RABI-767 along with standard care or just the standard care alone, and researchers will compare the results to understand how well the new treatment works.

To be eligible for this trial, participants must have a diagnosis of acute pancreatitis and show signs that it could become severe. They should not have improved significantly since being admitted to the hospital, and they need to be able to undergo the procedure to receive the treatment. The trial is currently looking for participants aged between 65 and 75, and it welcomes people of all genders. If you or someone you know is dealing with this condition and is interested in participating, this study could be an opportunity to help advance treatment options for acute pancreatitis.

Gender

ALL

Eligibility criteria

• 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