Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury

NCT02010034 | Completed DMC

• 1 other identifier: STU 112010-159
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.

Conditions

Liver Disease; Impaired Liver Function; Parenteral Nutrition Associated Liver Disease

Keywords

TPN; Liver Function; parenteral nutritional fat emulsions

Outcome Measures

Primary Outcomes (1)

• Bilirubin in mg/dL

  PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin 1\. after reaching bilirubin levels \>2mg/dl, subjects receiving Omegaven will reach a bilirubin level \< 2mg/dL faster that patients receiving conventional fat emulsions.

  12 weeks

Secondary Outcomes (1)

• Number of participants with adverse events

  12 weeks

Study Arms (1)

Compassionate use

OTHER

This lipid preparation is only being used for compassionate use.

Drug: Omegaven

Interventions

Omegaven DRUG

Omegaven will be used in place of soy oil Intralipid

Compassionate use

Eligibility Criteria

• Age: 2 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients must be 2 months -10 years of age
• Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
• Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of \>2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
• consecutive direct bilirubin test results \>2.0mg/dl
• The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall)
• Subjects who are currently under treatment for PNALD with Compassionate Use Omegaven and have a direct Bilirubin of\< 2, but who remain TPN dependent and require continued therapy with Omegaven

You may not qualify if:

• Other known causes of chronic liver disease (hepatitis C, cystic fibrosis, biliary atresia and alpha 1 anti-trypsin deficiency)
• Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
• The parent, guardian, or child is unwilling to provide consent or assent
• Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
• Active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis
• Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
• Unstable diabetes mellitus
• Stroke/embolism
• Collapse and shock
• Undefined coma status
• Active infection at time of initiation of Omegaven® up until such time as child is afebrile with stable vital signs and one negative 48 hour culture

Sponsors & Collaborators

• Children's Medical Center Dallas: lead

Study Sites (1)

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Nandini Channabasappa, MD

  Childrens Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Intestinal Rehabilitation Program

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: December 12, 2013
• Study Start: August 1, 2013
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)