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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 26
- 主要终点
- Change from Baseline in Hematology Parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard-of-Care Only
No Intervention, Standard-of-Care Only
RABI-767 plus Standard-of-Care
Single-dose 125 mg RABI-767 plus standard-of-care
干预措施: RABI-767 (Drug)
结局指标
主要结局
Change from Baseline in Hematology Parameters
时间窗: Baseline to Day 7
Number of Participants with Serious Adverse Events
时间窗: Enrollment/Randomization to Day 35 Follow-up
A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.
Change from Baseline in Vital Signs
时间窗: Baseline to Day 7
Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
时间窗: Baseline to Day 7
Number of Participants with Adverse Events
时间窗: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the study intervention, regardless of its causal relationship to the study intervention. For the purposes of this study, any AE occurring in any study participant (regardless of treatment group assignment) at any time after enrollment/randomization, even if no study intervention has been administered, will be recorded.
Change from Baseline in Clinical Chemistry Parameters
时间窗: Baseline to Day 7
次要结局
- Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis(From Baseline through Day 60 Follow-up)
- Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment(From Baseline through Day 28 (or hospital discharge, if earlier))
- Development of New Onset Moderately Severe Acute Pancreatitis(Day 1 to Day 28 (or hospital discharge, if earlier))
- Development of Pancreatic Necrosis(Baseline to Day 60 Follow-up)
- Development of Local Complications of Acute Pancreatitis(Baseline to Day 60 Follow-up)
- Days in Hospital(Day 1 through Day 28 (or hospital discharge, if earlier))
- Development of New Onset Infection(Day 1 to Day 28 (or hospital discharge, if earlier))
- Length of Stay in Intensive Care Unit(Day 1 through Day 28 (or hospital discharge, if earlier))
- Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis(Day 1 to Day 60 Follow-up)
- Mortality due to any cause(Day 1 to Day 60 Follow-up)
- Change in Modified Marshall Score(From Baseline through Day 28 (or hospital discharge, if earlier))
- Re-hospitalization for acute pancreatitis or related complications(From initial hospital discharge to Day 35 Follow-up)
- Change in Sequential Organ Failure Assessment (SOFA) Score(From Baseline through Day 28 (or hospital discharge, if earlier))
- Change in Abdominal Pain Numeric Rating Score(From Baseline through Day 28 (or hospital discharge, if earlier))
- Development of Severe Acute Pancreatitis(Day 1 to Day 28 (or hospital discharge, if earlier))
- Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis(From Baseline through Day 60 Follow-up)