Cholestasis Reversal: Efficacy of IV Fish Oil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL.
研究概览
简要总结
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
详细描述
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven), when used in lieu of the conventional soy-based fat emulsion (Intralipid), is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
- •Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of > 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- •Direct bilirubin > 2.0 mg/dl or already on Omegaven through another protocol
- •Signed patient informed consent.
- •The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).
排除标准
- •Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
- •Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- •The parent or guardian or child unwilling to provide consent or assent
- •In rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study. For the sake of statistical analysis, however, these patients will be excluded although all data will be collected and reviewed.
研究组 & 干预措施
Omegaven
1g/kg/day for duration of study participation for all participants
干预措施: Omegaven® (Drug)
结局指标
主要结局
Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL.
时间窗: Duration of treatment
Time to reversal of established parenteral nutrition associated liver disease, defined as a decrease in direct bilirubin to \<= 2.0 mg/dL.
次要结局
未报告次要终点
研究者
Mark Puder
M.D., Ph.D
Boston Children's Hospital