A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease

NCT00969332 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 09-02-079-02
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.

Conditions

Cholestasis

Keywords

liver; parenteral nutrition; fish oil; omegaven; children

Outcome Measures

Primary Outcomes (1)

• Time to Reversal of Parenteral Nutrition Associated Cholestasis

  weeks

  24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)

Secondary Outcomes (10)

• Death

  24 weeks, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)

• Number of Participants Who Underwent a Transplant

  24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)

• Time to Full Enteral Feeds

  24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)

• Growth Z-scores

  24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)

• Platelet Counts at the End of the Study - Risk of Bleeding

  24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)

Study Arms (1)

Omegaven

EXPERIMENTAL

0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.

Drug: Omegaven

Interventions

Omegaven DRUG

0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday

Omegaven

Eligibility Criteria

• Age: 2 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical evidence of parenteral nutrition associated cholestasis
• Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements
• Expected parenteral nutrition course greater than 30 days
• Acquired or congenital gastrointestinal disease
• \> 2 weeks of age and \< 18 years of age
• \> 60% calories from parenteral nutrition
• Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)

You may not qualify if:

• Inborn errors of metabolism
• Extracorporeal Membrane Oxygenation
• Seafood, egg, or Omegaven allergy
• Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis
• Hemorrhagic disorder
• Anticoagulant therapy
• Hemodynamically unstable or in shock
• Comatose state
• Stroke, pulmonary embolism, recent myocardial infarction
• Diabetes
• Fatal chromosomal disorder
• Enrollment in any other clinical trial involving an investigational agent
• Patient, parent, or legal guardians unable or unwilling to give consent
• Patient expected to be weaned from parenteral nutrition in 30 days
• unable to tolerate necessary monitoring

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• Calkins KL, Dunn JC, Shew SB, Reyen L, Farmer DG, Devaskar SU, Venick RS. Pediatric intestinal failure-associated liver disease is reversed with 6 months of intravenous fish oil. JPEN J Parenter Enteral Nutr. 2014 Aug;38(6):682-92. doi: 10.1177/0148607113495416. Epub 2013 Jul 26.

  PMID: 23894176 RESULT

• Calkins KL, DeBarber A, Steiner RD, Flores MJ, Grogan TR, Henning SM, Reyen L, Venick RS. Intravenous Fish Oil and Pediatric Intestinal Failure-Associated Liver Disease: Changes in Plasma Phytosterols, Cytokines, and Bile Acids and Erythrocyte Fatty Acids. JPEN J Parenter Enteral Nutr. 2018 Mar;42(3):633-641. doi: 10.1177/0148607117709196. Epub 2017 Dec 18.

  PMID: 28521607 RESULT

• Wang C, Venick RS, Shew SB, Dunn JCY, Reyen L, Gou R, Calkins KL. Long-Term Outcomes in Children With Intestinal Failure-Associated Liver Disease Treated With 6 Months of Intravenous Fish Oil Followed by Resumption of Intravenous Soybean Oil. JPEN J Parenter Enteral Nutr. 2019 Aug;43(6):708-716. doi: 10.1002/jpen.1463. Epub 2018 Nov 8.

  PMID: 30411372 RESULT

• Ong ML, Venick RS, Shew SB, Dunn JCY, Reyen L, Grogan T, Calkins KL. Intravenous Fish Oil and Serum Fatty Acid Profiles in Pediatric Patients With Intestinal Failure-Associated Liver Disease. JPEN J Parenter Enteral Nutr. 2019 Aug;43(6):717-725. doi: 10.1002/jpen.1532. Epub 2019 Mar 22.

  PMID: 30900274 RESULT

• Calkins KL, Thamotharan S, Ghosh S, Dai Y, Devaskar SU. MicroRNA 122 Reflects Liver Injury in Children with Intestinal Failure-Associated Liver Disease Treated with Intravenous Fish Oil. J Nutr. 2020 May 1;150(5):1144-1150. doi: 10.1093/jn/nxaa001.

  PMID: 32072161 DERIVED

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

early termination because intervention was FDA approved, single site study, prospective observational study, small sample size, change in clinical practice over time

Results Point of Contact

• Title: Dr. Kara L. Calkins
• Organization: UCLA

KCalkins@mednet.ucla.edu

310-825-9330

Study Officials

• Kara L Calkins, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: August 1, 2009
• Primary Completion: January 12, 2019
• Study Completion: February 12, 2019
• Last Updated: February 26, 2020
• Results First Posted: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)