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
- 7
- 主要终点
- To evaluate the safety of a single dose of RABI-767 administered by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only in adult participants with predicted severe acute pancreatitis.
研究概览
简要总结
This is a Phase 2a, multi-center, randomized, open-label, parallel-group study in adults with predicted severe acute pancreatitis to evaluate the safety and efficacy of a single dose of 125 mg (25 mL of 5 mg/mL) RABI-767 given by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only.
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.
All participants will be followed and study assessments recorded through Day 28 (± 1 day), or until hospital discharge, whichever occurs earlier. Two subsequent study follow-up study contacts will be completed on Day 35 (± 5 days) and Day 60 (± 7 days). Activities associated with this study, including screening and administration of study drug (if applicable), should not delay or preclude any aspect of standard-of-care in these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of current acute pancreatitis Adults 18-85 years of age.
- •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.
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 percentage pancreatic necrosis on screening CECT or MRI History of previous pancreatic necrosis, including necrosectomy History of calcific chronic pancreatitis Evidence of cholangitis.
结局指标
主要结局
To evaluate the safety of a single dose of RABI-767 administered by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only in adult participants with predicted severe acute pancreatitis.
时间窗: Day 28, Day 35, and Day 60
次要结局
- To evaluate the efficacy of a single dose of RABI-767 administered by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only in adult participants with predicted severe acute pancreatitis; and
研究者
Dr. Neeraj Prasad
JSS Medical Research Asia Pacific Private Limited