Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Cholestasis Clinical Trial

Official title:

Use of Omegaven for Parenteral Nutrition Associated Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194063
• Other study ID #: 107954
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2010
• Est. completion date: January 15, 2019

Study information

• Verified date: February 2019
• Source: Kapiolani Medical Center For Women & Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Description:

Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 15, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• direct bilirubin > 2 mg/dl x2 consecutive

• parenteral nutrition dependent, expected to continue for at least another 30 days from the first day

• patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion Criteria:

• other primary cause of liver disease not parenteral nutrition-associated

• weight <3 kg

• infant or child enrolled in other clinical trial involving an investigational agent

Related Conditions & MeSH terms

• Cholestasis
• Liver Diseases

Intervention

Drug:
• Omega-3 fish oil lipid emulsion
daily intravenous administration of Omegaven fish oil emulsion

Locations

Country	Name	City	State
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Kapiolani Medical Center For Women & Children

Country where clinical trial is conducted

United States, 

References & Publications (2)

de Meijer VE, Le HD, Meisel JA, Gura KM, Puder M. Parenteral fish oil as monotherapy prevents essential fatty acid deficiency in parenteral nutrition-dependent patients. J Pediatr Gastroenterol Nutr. 2010 Feb;50(2):212-8. doi: 10.1097/MPG.0b013e3181bbf51e. — View Citation

Lee SI, Valim C, Johnston P, Le HD, Meisel J, Arsenault DA, Gura KM, Puder M. Impact of fish oil-based lipid emulsion on serum triglyceride, bilirubin, and albumin levels in children with parenteral nutrition-associated liver disease. Pediatr Res. 2009 Dec;66(6):698-703. doi: 10.1203/PDR.0b013e3181bbdf2b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improving cholestasis	decline in serum direct bilirubin levels below 2 cm on 2 serial measures	One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
Secondary	improving liver function tests	includes ALT, AST, GGT, and triglycerides	1 year