Omegaven® as Parenteral Nutrition

Cholestasis Clinical Trial

Official title:

Omegaven® as Parenteral Nutrition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334293
• Other study ID #: 13055
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2015
• Last updated: January 7, 2015
• Start date: October 2013

Study information

• Verified date: January 2015
• Source: Carle Foundation Hospital
• Contact: Deveine Toney
• Phone: (217) 326-4504
• Email: deveine.toney[@]carle.com
• Is FDA regulated: No
• Health authority: United States: Carle Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

• Greater than 14 days old.

• Have PN-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.

• Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least 4 more weeks.

• Patients must have failed standard therapies for Parenteral Nutrition Associated Liver Disease (PNALD) including: cycling of PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and use of ursodiol (i.e. Actigall).

• Signed patient informed consent.

• The patient is expected to have a reasonable possibility of survival.

• No other known etiology of cholestasis other than PNALD at time of Omegaven® initiation.

Exclusion Criteria:

• Causes of cholestasis other than PNALD including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency, 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. Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs)

4. Active coagulopathy or bleeding

5. Thrombocytopenia

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

• Enrollment in a clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)

• The parent or guardian of child is unwilling to provide consent or assent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis

Intervention

Drug:
• Omegaven
Omegaven® fat emulsion will be used as a Compassionate Use treatment for critically ill infants with PN associated liver injury.

Locations

Country	Name	City	State
United States	Carle Foundation Hospital	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Carle Foundation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcomes/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin = 2 mg/dL or a direct bilirubin = 2 mg/dL and weaned from PN)	Primary efficacy analysis will include time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin = 2 mg/dL or a direct bilirubin = 2 mg/dL and weaned from PN).	Until weaned from PN	No
Secondary	Growth (weight three times per week, length once weekly, and head circumference)	At a minimum, monitoring of growth parameters while on Omegaven® will include weight three times per week, length once weekly, and head circumference once weekly.	Until weaned from PN	No
Secondary	Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)	We will monitor infants who are not receiving any enteral feeding at all for more than 4 weeks for any evidence of essential fatty acid (EFA) deficiency.	Until weaned from PN	No