- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325584
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
July 7, 2018 updated by: Pankaj Vashi, MD, Midwestern Regional Medical Center
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.
Study Overview
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).
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Zion, Illinois, United States, 60099
- Cancer Treatment Centers of America at Midwestern Regional Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Conjugated Bilirubin
Time Frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
|
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
Time Frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
|
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
Time Frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
|
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
Time Frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
|
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
Time Frame: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pankaj Vashi, MD, Midwestern Regional Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
March 25, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Actual)
August 7, 2018
Last Update Submitted That Met QC Criteria
July 7, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRMC 10-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
At present, no plan to share individual participant data.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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