Omegaven as Alternative Parenteral Fat Nutrition

Completed · Phase 3

Conditions studied: Cholestasis, Cholestasis of Parenteral Nutrition

In brief

To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis

Key facts

Study ID

NCT03662282

Run by

University of South Florida

People needed

2

Starts

2018-10-23

Expected to finish

2019-01-07

Last updated by the study team

2020-07-22

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than 14 days old
• Has parenteral nutrition associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4
• Patient is parenteral nutrition dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require parenteral nutrition for at least 3 more weeks
• Patient has not responded to other therapeutic approaches for parenteral nutrition-associated liver disease such as : cycling of parenteral nutrition, avoiding overfeeding, reduction/removal of copper and manganese from parenteral nutrition, advancement of enteral feeding, and use of Ursodiol
• Patient has been on at least 2 weeks of SMOFLIPIDs with no improvement or worsening of direct bilirubin levels
• Signed patient informed consent
• The patient is expected to have a reasonable possibility of survival
• No other known etiology of cholestasis other than parenteral nutrition-associated liver disease at the time of Omegaven® initiation

You may not qualify if…

• Known causes of cholestasis other than parenteral nutrition-associated liver disease including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 antitrypsin deficiency are present, prior to Omegaven® initiation
• Known fish or egg allergy
• Any of the contraindications to use of Omegaven®:
• Active new infection at the time of initiation of Omegaven®
• Hemodynamic instability
• Recent use of medications with associated risk of bleeding, including NSAIDs
• Active coagulopathy or bleeding
• Platelet counts persistently under 30,000 despite transfusions
• Unstable hyperglycemia
• Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
• History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
• Unstable diabetes mellitus
• Collapse and shock
• Stroke/ Embolism
• Cardiac infarction within the last 3 months
• Undefined coma status

Where it is running

• USF Health — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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