Omegaven as Alternative Parenteral Fat Nutrition

University of South Florida

Status and phase: Completed; Phase 3

Conditions: Cholestasis of Parenteral Nutrition; Cholestasis

Treatments: Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT03662282

00033519

Details and patient eligibility

About

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

Full description

An intermediate population, Investigational New Drug study, to provide an alternate intravenous fat nutrition, Omegaven®, to help improve liver function while providing adequate nutrition for critically ill infants with parenteral nutrition associated cholestasis

Enrollment: 2 patients

Sex: All

Ages: 14+ days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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®:

  1. Active new infection at the time of initiation of Omegaven®
  2. Hemodynamic instability
  3. Recent use of medications with associated risk of bleeding, including NSAIDs
  4. Active coagulopathy or bleeding
  5. Platelet counts persistently under 30,000 despite transfusions
  6. Unstable hyperglycemia
  7. Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
  8. History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
  9. Unstable diabetes mellitus
  10. Collapse and shock
  11. Stroke/ Embolism
  12. Cardiac infarction within the last 3 months
  13. Undefined coma status

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Drug - Omegaven®

Experimental group

Description:

Therapy with Omegaven® will be initiated at the goal dose of 0.5-1/kg/day. The default is over 24 hours, but shorter intervals may be considered if a program of total parenteral nutrition cycling is recommended. Omegaven® will be infused intravenously through either a central or peripheral catheter.

Treatment:

Drug: Omegaven