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
Latest Information Update: 21 Apr 2025
At a glance
- Drugs Soya oil emulsion/medium-chain triglyceride/olive oil/fish oil (Primary)
- Indications Malnutrition
- Focus Adverse reactions
- Sponsors Fresenius Kabi
Most Recent Events
- 25 Nov 2024 Status changed from not yet recruiting to recruiting.
- 27 Sep 2024 Planned initiation date changed from 1 Aug 2024 to 1 Oct 2024.
- 14 Aug 2024 Planned initiation date changed from 1 May 2024 to 1 Aug 2024.