RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-28
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06080789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of acute pancreatitis
  2. * Predicted severe acute pancreatitis, based on protocol defined criteria
  3. * Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization
  4. * Suitable for EUS-guided study drug administration procedure
  5. * Contrast-enhanced computed tomography (CECT) or magnetic resonance imaging (MRI) of the abdomen/pancreas available for the evaluation of exclusion criteria
  1. * 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
  2. * Anticipated discharge from hospital within 48 hours of randomization
  3. * More than 30% pancreatic necrosis on screening CECT or MRI
  4. * History of previous pancreatic necrosis, including necrosectomy
  5. * History of calcific chronic pancreatitis
  6. * Evidence of cholangitis

Contacts and Locations

Study Contact

Kelly Abernathy
CONTACT
9194609500
kabernathy@arrivobio.com

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Keck Hospital of USC and LA County Hospital
Los Angeles, California, 90033
United States
University of Florida Health
Gainesville, Florida, 32608
United States
Orlando Health
Orlando, Florida, 32806
United States
UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, Illinois, 60612
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
NYU Langone Medical Center
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: Panafina, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28
Study Completion Date2025-10

Study Record Updates

Study Start Date2024-06-28
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Pancreatitis