Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Children's Mercy Hospital Kansas City

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parenteral Nutrition-related Hepatitis

Treatments: Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT04697888

12010063

Details and patient eligibility

About

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

Full description

This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Enrollment: 2 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Overall Study

Experimental group

Description:

Use of Omegaven for patients with parenteral nutrition associated liver disease.

Treatment:

Drug: Omegaven