Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Recruiting Phase 4 Interventional Study
Malnutrition, Child Malnutrition Essential Fatty Acid Deficiency (EFAD) Parenteral Nutrition Associated Cholestasis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 Month – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Other
Participants needed
100 (estimated)
Sponsor
Fresenius Kabi · Industry
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About This Trial

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.

Trial Locations
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Eligibility Criteria
Age Limits: and Adults Inclusion Criteria: 1. Male or female patients, at least 1 month of age. 2. Patients who require PN for at least 5 days/week. 3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total…
Contacts

Martin Stumpf, PhD

+49 6172 686

martin.stumpf@fresenius-kabi.com

CONTACT

Jean-Marc Lohse, PhD

+49 6172 686

Jean-Marc.Lohse@fresenius-kabi.com

CONTACT