Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01089426 | Completed DMC

• 1 other identifier: CCI-08-00127
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the hypothesis that administering intravenous fish oil, in lieu of intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30 days.

Conditions

Liver Injury

Keywords

Pediatric patients with Parenteral Nutrition (PN) induced Liver Injury

Outcome Measures

Primary Outcomes (1)

• Rate of reduction of direct bilirubin

  normalization of direct bilirubin: an expected average of approximately 5 months

Study Arms (2)

Historical controls

OTHER

A subset of patients previously seen, who have had at least 2 consecutive direct bilirubin levels \> 2 mg/dL, who depended on parenteral nutrition for at least 90 days after surgical therapy for congenital or acquired intestinal diseases

Other: Historical Controls

Omegaven™

EXPERIMENTAL

Drug: Omegaven™

Interventions

Omegaven™ DRUG

1 g/kg/d of Omegaven until discontinuation of PN

Also known as: Highly refined fish oil for intravenous administration (10% Omegaven™)

Omegaven™

Historical Controls OTHER

Standard of Care

Historical controls

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients will be parenteral nutrition dependent and are expected to require PN for at least another 30 days
• Patients must have parenteral nutrition associated liver disease (PNALD) as defined by having at least 2 consecutive direct bilirubins \>2 mg/dl.

You may not qualify if:

• Pregnancy
• Other causes of liver disease
• Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
• Direct bilirubin \< 2 mg/dl
• Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
• Active coagulopathy characterized by on-going bleeding or acute need for clotting factor replacement such as FFP or cryoprecipitate to maintain homeostasis
• Impaired lipid metabolism as defined by serum Tg level \>400 at time of initiation of Omegaven
• Unstable diabetes mellitus
• Recent stroke/embolism, not including catheter related thrombosis, which is a common complication of central venous catheter.
• Collapse and shock
• Undefined coma status
• Untreated infection at time of initiation of Omegaven
• Hemodynamic instability
• \> 21 years of age

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Childrens Hospital Los Angeles

Los Angeles, California, 90027-6016, United States

Location

Related Publications (30)

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MeSH Terms

Interventions

fish oil triglycerides; Administration, Intravenous

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Russell Merritt, M.D., PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Nutrition Support and Intestinal Rehabilitation

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 18, 2010
• Study Start: September 1, 2008
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

US (1)