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临床试验/NCT01194063
NCT01194063已完成3 期

Use of Omegaven for Parenteral Nutrition Associated Liver Disease

Kapiolani Medical Center For Women & Children1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年10月20日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

发起方
Kapiolani Medical Center For Women & Children
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lynn M. Iwamoto

MD, Associate Professor of Pediatrics

Kapiolani Medical Center For Women & Children

研究点 (1)

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