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

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

Sponsors

Lead sponsor: Midwestern Regional Medical Center

Source Midwestern Regional Medical Center
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).

Overall Status Terminated
Start Date October 2012
Completion Date April 2017
Primary Completion Date December 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Maximum Conjugated Bilirubin Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Average Change in Alkaline Phosphatase Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Number of Patients Experiencing Adverse Events Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Average Improvement in AST Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Average Improvement in ALT Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Enrollment 12
Condition
Intervention

Intervention type: Drug

Intervention name: Omegaven

Description: 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. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). 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. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.

Arm group label: Omegaven (compassionate use)

Other name: fish oil

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pankaj Vashi, MD Principal Investigator Midwestern Regional Medical Center
Location
facility Cancer Treatment Centers of America at Midwestern Regional Medical Center
Location Countries

United States

Verification Date

July 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Pankaj Vashi, MD

Investigator title: Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Omegaven (compassionate use)

Arm group type: Experimental

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

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov