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

Malnutrition Clinical Trial

Official title:
A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) and/or Parenteral Nutrition-associated Cholestasis (PNAC) in Pediatric Patients 1 Month to 17 Years of Age and in Adult Patients, Who Are Anticipated to Need 8 Weeks or Longer of Parenteral Nutrition Treatment

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06049680
Study type Interventional
Source Fresenius Kabi
Contact Cornelia Schneider-Schranz, PhD
Phone +49 6172 608
Email Cornelia.Schneider-Schranz@fresenius-kabi.com
Status Not yet recruiting
Phase Phase 4
Start date May 2024
Completion date September 2026
View Details
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