Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

NCT01173159 | Completed Results DMC

• 1 other identifier: 2009-2314
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.

Conditions

Cholestasis

Keywords

Parenteral Nutrition; Cholestasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Change in Conjugated/Direct Bilirubin

  Change in conjugated/direct bilirubin level to below 1 mg/dl.

  Completion of Therapy (time frame from 1-14 weeks)

Secondary Outcomes (6)

• Number of Participants With a Change in Unconjugated/Total Bilirubin

  Completion of Therapy (time frame from 1-14 weeks)

• Number of Participants With a Change in Aspartate Transaminase (AST)

  Completion of Therapy (time frame from 1-14 weeks)

• Number of Participants With a Change in Liver Enzyme (ALT)

  Completion of Therapy (time frame from 1-14 weeks)

• Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase

  Completion of Therapy (time frame from 1-14 weeks)

• Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)

  Completion of Therapy (time frame from 1-14 weeks)

Study Arms (1)

Omegaven

EXPERIMENTAL

Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.

Drug: Omegaven

Interventions

Omegaven DRUG

For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site.

Omegaven

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females ages one month of age to 18 years of age
• Patients with intestinal failure on TPN
• Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
• Patients in whom reduction of IV soy-based lipid to an average \<1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
• Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
• Signed informed consent for use of Omegaven® obtained

You may not qualify if:

• Any of the contraindications to use of Omegaven®
• Impaired lipid metabolism (triglycerides \>1000 mg/dL) while on
• 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
• Undefined coma status
• Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
• Females of child-bearing potential who are unwilling to use birth control during study participation
• Parental decision to forego the use of Omegaven®
• Known fish or egg allergy
• Pregnancy
• Causes of liver disease other than Parenteral Nutrition Associated Cholestasis

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Cholestasis; Hyperphagia

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We enrolled very few patients so that we have too small a cohort with which to assess achievement of our outcomes.

Results Point of Contact

• Title: Crystal Slaughter, BA, CCRC
• Organization: Cincinnati Children's Hospital Medical Center

crystal.slaughter@cchmc.org

513-636-0137

Study Officials

• Samuel Kocoshis, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 29, 2010
• First Posted: July 30, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 17, 2020
• Results First Posted: May 8, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)