Omegaven as Alternative Parenteral Fat Nutrition

Cholestasis Clinical Trial

Official title:

Omegaven as Alternative Parenteral Fat Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662282
• Other study ID #: 00033519
• Status: Completed
• Phase: Phase 3
• Start date: October 23, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: July 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis of Parenteral Nutrition

Intervention

Drug:
• Omegaven
Omegaven® fat emulsion will be used as a compassionate use treatment for critically ill infants with parenteral nutrition associated liver injury

Locations

Country	Name	City	State
United States	USF Health	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participant With Decrease in Direct Bilirubin Level	Number of participant with decrease in direct bilirubin levels within 30 days of treatment	First month of treatment
Secondary	Number of Participant With Resolution of Direct Hyperbilirubinemia	Number of participant with Direct bilirubin level of <2mg/dL at discontinuation of treatment	2 months
Secondary	Number of Participant With Preservation of Length	Monitoring of weekly length while the patient is receiving Omegaven® treatment	Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment
Secondary	Number of Participant With Preservation of Head Circumference	Monitoring of weekly head circumference while the patient is receiving Omegaven® treatment	Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment
Secondary	Number of Participant With Preservation of Normal Weight Gain	Monitoring of daily weight gain while the patient is on Omegaven®	Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment