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

Stopped early · Phase 2

Conditions studied: Cancer, Hepatic Injury

In brief

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.

Key facts

Study ID

NCT01325584

Run by

Midwestern Regional Medical Center

People needed

12

Starts

2012-10-01

Expected to finish

2017-04-01

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Treatment Centers of America at Midwestern Regional Medical Center — Zion, Illinois, United States

Full record on ClinicalTrials.gov

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