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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Number of Participants with Adverse Events [Срок оценки: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)]
• Number of Participants with Serious Adverse Events [Срок оценки: Enrollment/Randomization to Day 35 Follow-up]
• Change from Baseline in Clinical Chemistry Parameters [Срок оценки: Baseline to Day 7]
• Change from Baseline in Hematology Parameters [Срок оценки: Baseline to Day 7]
• Change from Baseline in Vital Signs [Срок оценки: Baseline to Day 7]
• Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements [Срок оценки: Baseline to Day 7]

Вторичные конечные точки (12)

• Development of Severe Acute Pancreatitis [Срок оценки: Day 1 to Day 28 (or hospital discharge, if earlier)]
• Development of New Onset Moderately Severe Acute Pancreatitis [Срок оценки: Day 1 to Day 28 (or hospital discharge, if earlier)]
• Development of Pancreatic Necrosis [Срок оценки: Baseline to Day 60 Follow-up]
• Development of Local Complications of Acute Pancreatitis [Срок оценки: Baseline to Day 60 Follow-up]
• Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis [Срок оценки: Day 1 to Day 60 Follow-up]
• Mortality due to any cause [Срок оценки: Day 1 to Day 60 Follow-up]
• Days in Hospital [Срок оценки: Day 1 through Day 28 (or hospital discharge, if earlier)]
• Re-hospitalization for acute pancreatitis or related complications [Срок оценки: From initial hospital discharge to Day 35 Follow-up]
• Length of Stay in Intensive Care Unit [Срок оценки: Day 1 through Day 28 (or hospital discharge, if earlier)]
• Development of New Onset Infection [Срок оценки: Day 1 to Day 28 (or hospital discharge, if earlier)]
• Change in Modified Marshall Score [Срок оценки: From Baseline through Day 28 (or hospital discharge, if earlier)]
• Change in Sequential Organ Failure Assessment (SOFA) Score [Срок оценки: From Baseline through Day 28 (or hospital discharge, if earlier)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 11 центров

• University of Arkansas for Medical Sciences — Little Rock
• Keck Hospital of USC and LA County Hospital — Los Angeles
• University of Colorado Anschutz Medical Campus — Aurora
• University of Florida Health — Gainesville
• Orlando Health — Orlando
• UI Health, University of Illinois Chicago Hospital Health Sciences System — Chicago
• Indiana University Health University Hospital — Indianapolis
• Johns Hopkins Hospital — Baltimore
• … и ещё 3 центра

Индия · 5 центров

• Lisie Hospital — Kochi
• Christian Medical College (CMC) Vellore, Ranipet Campus — Vellore
• Postgraduate Institute of Medical Education and Research — Chandigarh
• All India Institute of Medical Sciences — Delhi
• Govind Ballabh Pant Institute of Postgraduate Medical Education and Research — New Delhi

Идентификаторы

NCT: NCT06080789 · RABI-767-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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