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

NCT ID: NCT01325584

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-04-30

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).

Conditions

Cancer; Hepatic Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omegaven (compassionate use)

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

Group Type: EXPERIMENTAL

Omegaven

Intervention Type: DRUG

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.

Interventions

Omegaven

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.

Intervention Type: DRUG

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Midwestern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Pankaj Vashi, MD

Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pankaj Vashi, MD

Role: PRINCIPAL_INVESTIGATOR

Midwestern Regional Medical Center

Locations

Cancer Treatment Centers of America at Midwestern Regional Medical Center

Zion, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

MRMC 10-06

Identifier Type: -

Identifier Source: org_study_id