Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

Midwestern Regional Medical Center

Status and phase: Terminated; Phase 2

Conditions: Cancer; Hepatic Injury

Treatments: Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT01325584

MRMC 10-06

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female; ages 18 to 80 years old
2. Receiving treatment at Cancer Treatment Centers of America
3. Receiving PN (either in the infusion center or at home)
4. 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
5. Able to provide informed written consent

Exclusion criteria

1. Hypertriglyceridemia (triglycerides [TG] > 400)
2. Allergy to fish or egg protein
3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
4. Hemodynamically unstable
5. Bilirubin > 5 mg/dL
6. Documented liver metastases
7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
8. Recent cardiac infarction (within 6 months) and taking plavix
9. Severe hemorrhagic disorders
10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism
11. Active sepsis
12. Undefined coma status
13. In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min
14. Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Omegaven (compassionate use)

Experimental group

Description:

This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

Treatment:

Drug: Omegaven