NCT00040131终止2 期
Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 316
研究概览
简要总结
The purpose of this study is to determine if a single dose of IL-10 compared to placebo is safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects with increased risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults weighing up to 125 kg who are undergoing ERCP for any of the following:
- •Evaluate recurrent abdominal pain;
- •Evaluate unexplained recurrent pancreatitis;
- •Evaluate prior post-ERCP pancreatitis;
- •Treatment of pancreatic disorders;
- •Treatment of Common Bile Duct Stones (without jaundice)
排除标准
- •Active (acute) pancreatitis;
- •Chronic pancreatitis (moderate and severe cases);
- •ERCP to perform a second procedure on biliary tract;
- •Patients who previously had pancreatic sphincterotomy;
- •Known or suspected pancreatic cancer or cancer of Papilla of Vater;
- •Known or suspected other malignancy;
- •History of, or current clotting or bleeding problems;
- •Moderate and severe Anemia;
- •Low platelet counts
研究者
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