Omegaven Expanded Access Protocol
| Status: | Available |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 10/12/2017 |
| Contact: | Allyson Reynolds, NP |
| Email: | renolal@slhs.org |
| Phone: | 208-381-7370 |
Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from
fish oil. It will be used in an open label compassionate use treatment protocol, as an
alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an
effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will
evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and
PNALD.
fish oil. It will be used in an open label compassionate use treatment protocol, as an
alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an
effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will
evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and
PNALD.
Inclusion Criteria:
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral
nutrition) and are expected to require PN for at least another 30 days
- Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin
of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver
disease should be excluded. A liver biopsy is not necessary for treatment.
- Failed standard/conventional therapies to prevent progression of PNALD.
- Age newborn to 17 years of age
- Signed informed consent.
Exclusion Criteria:
- Allergy to eggs and/or shellfish
- Female who is pregnant or lactating
- Severe hemorrhagic disorder
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia,
and alpha 1 anti-trypsin deficiency,)
- 18 years of age or older
- Parent/legally authorized representative is unwilling to consent.
We found this trial at
1
site
100 East Idaho Street
Boise, Idaho 83712
Boise, Idaho 83712
Principal Investigator: Tyler Burpee, MD
Phone: 208-381-7370
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