RecruitingPhase 2NCT06080789

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


Sponsor

Panafina, Inc.

Enrollment

36 participants

Start Date

Jun 28, 2024

Study Type

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called RABI-767 for people with acute pancreatitis. The study is currently recruiting participants at 16 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRABI-767

125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.


Locations(16)

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 Colorado Anschutz Medical Campus

Aurora, Colorado, 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

Henry Ford Hospital

Detroit, Michigan, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

NYU Langone Medical Center

New York, New York, United States

Lisie Hospital

Kochi, Kerala, India

Christian Medical College (CMC) Vellore, Ranipet Campus

Vellore, TamiNadu, India

Postgraduate Institute of Medical Education and Research

Chandigarh, India

All India Institute of Medical Sciences

Delhi, India

Govind Ballabh Pant Institute of Postgraduate Medical Education and Research

New Delhi, India

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06080789


Related Trials