Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Recruiting Observational Study
Parenteral Nutrition Associated Liver Disease (PNALD) Essential Fatty Acid Deficiency Malnutrition Pediatric ALL
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
1 Day – 17
Sex
Any
Study type
Observational
Participants needed
40 (estimated)
Sponsor
Fresenius Kabi · Industry
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About This Trial

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF). 2. Pediatric patient (\<18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liver dysfunction at…
Contacts

Niess Ulf, PhD

M +49 173 5439924

ulf.niess@fresenius-kabi.com

CONTACT

Lohse Jean-Marc, PhD

+49 173 5420453

Jean-Marc.Lohse@fresenius-kabi.com

CONTACT