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

NCT01325584 | Terminated Phase 2 Results

• 1 other identifier: MRMC 10-06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Hepatic Injury

Outcome Measures

Primary Outcomes (5)

• Maximum Conjugated Bilirubin

  Highest detected lab values will be summarized between baseline and end of study participation.

  Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

• Average Change in Alkaline Phosphatase

  lab values will be summarized at baseline and as change from baseline to worst follow-up value.

  Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

• Number of Patients Experiencing Adverse Events

  The number of patients reporting or experiencing adverse effects will be reported.

  Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

• Average Improvement in AST

  Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.

  Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

• Average Improvement in ALT

  Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value

  Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

Study Arms (1)

Omegaven (compassionate use)

EXPERIMENTAL

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

Drug: Omegaven

Interventions

Omegaven 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.

Also known as: fish oil

Omegaven (compassionate use)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Midwestern Regional Medical Center: lead

Study Sites (1)

Cancer Treatment Centers of America at Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

fish oil triglycerides; Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Midwestern Regional Medical Center

Bruce.Steinert@CTCA-Hope.com

847-731-1648

Study Officials

• Pankaj Vashi, MD

  Midwestern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 30, 2011
• Study Start: October 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: August 7, 2018
• Results First Posted: June 27, 2018

Record last verified: 2018-07

Locations

US (1)