Use of Omegaven for Parenteral Nutrition Associated Liver Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- improving cholestasis
研究概览
简要总结
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
详细描述
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.
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 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •direct bilirubin > 2 mg/dl x2 consecutive
- •parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
- •patient must have utilized standard therapies to prevent the progression of liver disease
排除标准
- •other primary cause of liver disease not parenteral nutrition-associated
- •weight <3 kg
- •infant or child enrolled in other clinical trial involving an investigational agent
研究组 & 干预措施
Omegaven
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
干预措施: Omega-3 fish oil lipid emulsion (Drug)
结局指标
主要结局
improving cholestasis
时间窗: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
decline in serum direct bilirubin levels below 2 cm on 2 serial measures
次要结局
- improving liver function tests(1 year)
研究者
Lynn M. Iwamoto
MD, Associate Professor of Pediatrics
Kapiolani Medical Center For Women & Children
