CompletedPhase 2/3

Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

United States2 participantsStarted 2013-04

Plain-language summary

To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
✓. Patient will be \<18 years of age.
✓. Direct bilirubin \> 2.0mg/dl
✓. The patient must have failed standard therapies to prevent progression his/her liver disease.

✕. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
✕. Patients who are allergic to eggs/shellfish
✕. Patients who have severe hemorrhagic disorders.

Disease Progression as Measured by Serum Levels of Hepatic Enzymes

Timeframe: Up to 1 year

NCT IDNCT04697888

SponsorChildren's Mercy Hospital Kansas City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11

Results submitted2021-01-07