NCT02334293

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

3.8 years

First QC Date

January 6, 2015

Last Update Submit

January 7, 2015

Conditions

Cholestasis

Keywords

Omegavenparenteral nutritionliver diseaseliver injury

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Growth (weight three times per week, length once weekly, and head circumference)

    Until weaned from PN

  • Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)

    Until weaned from PN

Study Arms (1)

Omegaven

OTHER
Drug: Omegaven

Interventions

OmegavenDRUG

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

Omegaven

Eligibility Criteria

Age14 Days - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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®:
  • Active new infection at the time of initiation of Omegaven®
  • Hemodynamic instability
  • Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs)
  • Active coagulopathy or bleeding
  • Thrombocytopenia
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

CholestasisHyperphagiaLiver Diseases

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Stratton, MD

    Carle Foundation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deveine Toney

CONTACT

(217) 326-4504deveine.toney@carle.com

Mary Baker

CONTACT

(217)326-0058clinicaltrials@carle.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

October 1, 2013

Primary Completion

July 1, 2017

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

US(1)