Omegaven as Alternative Parenteral Fat Nutrition

NCT ID: NCT03662282

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2019-01-07

Brief Summary

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

Detailed 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

Conditions

Cholestasis; Cholestasis of Parenteral Nutrition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug - Omegaven®

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.

Group Type: EXPERIMENTAL

Omegaven

Intervention Type: DRUG

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

Interventions

Omegaven

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thao Ho, DO

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

USF Health

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

00033519

Identifier Type: -

Identifier Source: org_study_id