NCT02148146No Longer Available不适用
Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 2
研究概览
简要总结
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
详细描述
Specific Aims of Study
- To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)
- To determine if established PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.
研究设计
- 研究类型
- Expanded Access
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
- •Age < 18 years old
- •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, may be inpatient or outpatient
- •Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
- •Direct bilirubin > 2.0 mg/dl
- •Signed patient informed consent
- •The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, or the use of ursodiol (i.e., Actigall®)
排除标准
- •Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)
- •Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- •The parent or guardian or child unwilling to provide consent or assent
- •Patients known to be allergic to fish or egg protein and patients with the following contraindications to Omegaven™ use:
- •Impaired lipid metabolism
- •Severe hemorrhagic disorders
- •Unstable diabetes mellitus
- •Collapse and shock
- •Stroke/embolism
- •Recent cardiac infarction
- •Undefined coma status
研究者
研究点 (2)
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