Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
18 Years
80 Years
Both
Cancer, Hepatic Injury
Trial Information
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
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).
Inclusion Criteria:
1. Male or Female; ages 18 to 80 years old
2. Receiving treatment at CTCA
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 (patient or legally acceptable
representative)
Exclusion Criteria:
1. Hypertriglyceridemia (fasting 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 progression of liver metastases
7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
8. Recent cardiac infarction taking plavix
9. Severe hemorrhagic disorders
10. Embolism
11. Sepsis
12. Undefined coma status
13. Renal insufficiency with calculated creatinine clearance < 30 mL/min
14. Pregnancy or lactation
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
maximum conjugated bilirubin
Outcome Time Frame:
up to 4 weeks
Safety Issue:
No
Principal Investigator
Pankaj Vashi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Midwestern Regional Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
MRMC 10-06
NCT ID:
NCT01325584
Start Date:
October 2012
Completion Date:
December 2013
Related Keywords:
- Cancer
- Hepatic Injury
Name | Location |
|---|---|
| Cancer Treatment Centers of America at Midwestern Regional Medical Center | Zion, Illinois 60099 |
