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Clinical trial

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

NCT06049680 is registered in ClinicalTrials.gov with Fresenius Kabi as lead sponsor.

NCT NCT06049680
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Fresenius Kabi
Phase
Phase 4
Overall status
Recruiting
Start date
October 28, 2024
Completion date
September 30, 2026
Enrollment
100 (estimated)
Sites
5

Conditions

As the registry lists them; a condition with its own page is linked.

essential fatty acid deficiency (efad), malnutrition, malnutrition, child, parenteral nutrition associated cholestasis