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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Panafina, Inc.
Study ID
NCT06080789
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • RABI-767 — DRUG
    125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.

Study Details

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.

Key Dates

Start date
Jun 28, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RABI-767 plus Standard-of-Care
    Single-dose 125 mg RABI-767 plus standard-of-care
  • No Intervention: Standard-of-Care Only
    No Intervention, Standard-of-Care Only

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Clinical Research Coordinator
501-526-4860
Keck Hospital of USC and LA County HospitalLos AngelesCalifornia90033
Clinical Research Coordinator
323-409-6939
University of Colorado Anschutz Medical CampusAuroraColorado80045
Clinical Research Coordinator
303-724-1871
University of Florida HealthGainesvilleFlorida32608
Clinical Research Coordinator
352-273-9483
Orlando HealthOrlandoFlorida32806
Clinical Research Coordinator
321-841-6649
UI Health, University of Illinois Chicago Hospital Health Sciences SystemChicagoIllinois60612
Clinical Research Coordinator
630-518-5456
Indiana University Health University HospitalIndianapolisIndiana46202-
Johns Hopkins HospitalBaltimoreMaryland21287
Clinical Research Coordinator
410-614-6708
Henry Ford HospitalDetroitMichigan48202
Clinical Research Coordinator
313-746-8215
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756
Clinical Research Coordinator
603-653-3651
NYU Langone Medical CenterNew YorkNew York10016
Clinical Research Coordinator
212-263-3095

Find similar trials in Little Rock, AR

By research site
University of Arkansas for Medical Sciences· Little Rock, ARKeck Hospital of USC and LA County Hospital· Los Angeles, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COUniversity of Florida Health· Gainesville, FLOrlando Health· Orlando, FLUI Health, University of Illinois Chicago Hospital Health Sciences System· Chicago, IL

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