Clinical trial NCT01325584: Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Official title: Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Hepatic Injury
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Maximum Conjugated Bilirubin
timeFrame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
measure: Average Change in Alkaline Phosphatase
timeFrame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
measure: Number of Patients Experiencing Adverse Events
timeFrame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
measure: Average Improvement in AST
timeFrame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
measure: Average Improvement in ALT
timeFrame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Zion
country: United States
facility: Cancer Treatment Centers of America at Midwestern Regional Medical Center
state: Illinois
Study officials:
affiliation: Midwestern Regional Medical Center
name: Pankaj Vashi, MD
role: PRINCIPAL_INVESTIGATOR
References: