Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With a Change in Conjugated/Direct Bilirubin
研究概览
简要总结
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
详细描述
Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages one month of age to 18 years of age
- •Patients with intestinal failure on TPN
- •Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
- •Patients in whom reduction of IV soy-based lipid to an average <1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
- •Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
- •Signed informed consent for use of Omegaven® obtained
排除标准
- •Any of the contraindications to use of Omegaven®
- •Impaired lipid metabolism (triglycerides >1000 mg/dL) while on
- •1g/kg/day or less of Intralipid
- •History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- •Unstable diabetes mellitus
- •Collapse and shock
- •Stroke/ Embolism
- •Cardiac infarction within the last 3 months
- •Undefined coma status
- •Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
- •Females of child-bearing potential who are unwilling to use birth control during study participation
- •Parental decision to forego the use of Omegaven®
- •Known fish or egg allergy
- •Pregnancy
- •Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
研究组 & 干预措施
Omegaven
Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
干预措施: Omegaven (Drug)
结局指标
主要结局
Number of Participants With a Change in Conjugated/Direct Bilirubin
时间窗: Completion of Therapy (time frame from 1-14 weeks)
Change in conjugated/direct bilirubin level to below 1 mg/dl.
次要结局
- Number of Participants With a Change in Unconjugated/Total Bilirubin(Completion of Therapy (time frame from 1-14 weeks))
- Number of Participants With a Change in Aspartate Transaminase (AST)(Completion of Therapy (time frame from 1-14 weeks))
- Number of Participants With a Change in Liver Enzyme (ALT)(Completion of Therapy (time frame from 1-14 weeks))
- Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase(Completion of Therapy (time frame from 1-14 weeks))
- Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)(Completion of Therapy (time frame from 1-14 weeks))
- Number of Participants With a Change in Triglycerides(Completion of Therapy (time frame from 1-14 weeks))