Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Conjugated Bilirubin
研究概览
简要总结
The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.
详细描述
This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients > 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids & benadryl will be administered & Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female; ages 18 to 80 years old
- •Receiving treatment at Cancer Treatment Centers of America
- •Receiving PN (either in the infusion center or at home)
- •Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction
- •Able to provide informed written consent
排除标准
- •Hypertriglyceridemia (triglycerides [TG] > 400)
- •Allergy to fish or egg protein
- •Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
- •Hemodynamically unstable
- •Bilirubin > 5 mg/dL
- •Documented liver metastases
- •Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
- •Recent cardiac infarction (within 6 months) and taking plavix
- •Severe hemorrhagic disorders
- •Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism
- •Active sepsis
- •Undefined coma status
- •In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min
- •Pregnancy or lactation
研究组 & 干预措施
Omegaven (compassionate use)
This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.
干预措施: Omegaven (Drug)
结局指标
主要结局
Maximum Conjugated Bilirubin
时间窗: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Highest detected lab values will be summarized between baseline and end of study participation.
Average Improvement in ALT
时间窗: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value
Average Change in Alkaline Phosphatase
时间窗: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
lab values will be summarized at baseline and as change from baseline to worst follow-up value.
Number of Patients Experiencing Adverse Events
时间窗: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
The number of patients reporting or experiencing adverse effects will be reported.
Average Improvement in AST
时间窗: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.
次要结局
未报告次要终点
研究者
Pankaj Vashi, MD
Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support
Midwestern Regional Medical Center