NCT02121769No Longer Available不适用
Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375
St. Luke's Health System, Boise, Idaho1 个研究点 分布在 1 个国家开始时间: 2014年4月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.
研究设计
- 研究类型
- Expanded Access
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
- •Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- •Failed standard/conventional therapies to prevent progression of PNALD.
- •Age newborn to 17 years of age
- •Signed informed consent.
排除标准
- •Allergy to eggs and/or shellfish
- •Female who is pregnant or lactating
- •Severe hemorrhagic disorder
- •Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
- •18 years of age or older
- •Parent/legally authorized representative is unwilling to consent.
研究者
Tyler Burpee, MD
Principal Investigator
St. Luke's Health System, Boise, Idaho
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver DiseaseParenteral Nutrition-related HepatitisNCT04697888Children's Mercy Hospital Kansas City2
No Longer Available
不适用
Compassionate Use of Omegaven IV Fat EmulsionCholestasisLiver DiseaseNCT02477345Northwell Health
终止
2 期
Compassionate Use of Omegaven IV Fat EmulsionCholestasisTotal Parenteral Nutrition-induced CholestasisNCT00816348Cindy Haller15
Unknown
不适用
Omegaven® as Parenteral NutritionCholestasisNCT02334293Carle Foundation Hospital25
Approved For Marketing
不适用
Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver DiseaseCholestasisShort Bowel SyndromeNCT01297933Children's Hospital of Philadelphia