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NCT04807478
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
trial testing Omegaven® (fish oil triglycerides) Injectable Emulsion in Parenteral Nutrition Associated Liver Disease. Withdrawn.
1 May 2028
Quick facts
| Lead sponsor | Fresenius Kabi |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 April 2022 |
| Primary completion | 1 May 2028 |
| Estimated completion | 1 May 2029 |
Drugs / interventions tested
- Omegaven® (fish oil triglycerides) Injectable Emulsion — full drug profile →
Conditions studied
- Parenteral Nutrition Associated Liver Disease — all drugs for Parenteral Nutrition Associated Liver Disease →
- Essential Fatty Acid Deficiency — all drugs for Essential Fatty Acid Deficiency →
- Neurocognitive Deficit — all drugs for Neurocognitive Deficit →
- Malnutrition — all drugs for Malnutrition →
Sponsor
Fresenius Kabi — full company profile →
Who can join
1 Day and older, any sex, with Parenteral Nutrition Associated Liver Disease or Essential Fatty Acid Deficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will demonstrate Short-, mid-, and long-term 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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04807478
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Omegaven® (fish oil triglycerides) Injectable Emulsion
Trials testing the same drug.
- NCT06274788 — Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Ome · recruiting
Other Fresenius Kabi trials
Trials by the same sponsor.
- NCT06274788 — Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Ome · recruiting
- NCT05190484 — bIosimilar of aDalimumab, an European evAluation · unknown
- NCT05257031 — Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care · Phase 3 · completed
- NCT05051943 — A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Respon · completed
- NCT03563222 — Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age · Phase 4 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04807478 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fresenius Kabi
- Last refreshed: 4 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04807478.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing