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

• Status: Terminated
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Midwestern Regional Medical Center

Criteria

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