Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Disease Progression as Measured by Serum Levels of Hepatic Enzymes
研究概览
简要总结
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).
详细描述
This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
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
- •The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
- •Patient will be <18 years of age.
- •Direct bilirubin > 2.0mg/dl
- •The patient must have failed standard therapies to prevent progression his/her liver disease.
排除标准
- •Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
- •Patients who are allergic to eggs/shellfish
- •Patients who have severe hemorrhagic disorders.
研究组 & 干预措施
Overall Study
Use of Omegaven for patients with parenteral nutrition associated liver disease.
干预措施: Omegaven (Drug)
结局指标
主要结局
Disease Progression as Measured by Serum Levels of Hepatic Enzymes
时间窗: Up to 1 year
To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes.
次要结局
未报告次要终点