Drugs / SMOFlipid
SMOFlipid
Trials 26 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03405870 | Aug 2018 → Apr 2023 | infectious disease with sepsis | University of Florida | Completed | No outcome recorded |
| Phase 1/2 | NCT02721277 | May → Dec 2016 | obstructive jaundice | University of Florida | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04031508 | Aug 2019 → Nov 2026 expected | congenital diaphragmatic hernia, pulmonary hypertension, neonatal | Coordinación de Investigación en Salud, Mexico | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT00793195 | Jan 2009 → Sep 2011 | chronic intestinal failure, intestinal motility disease, short bowel syndrome | The Hospital for Sick Children | Unknown | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT04957940 | Jul → Sep 2021 | COVID-19 | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT04523701 | Mar 2021 → Dec 2025 overdue | bile duct disorder | Giulia Manzini | Recruiting | No outcome recorded |
| Phase 3 | NCT03387579 | Nov 2018 → Mar 2021 | parenteral nutrition-associated cholestasis | Indiana University | Completed | No outcome recorded |
| Phase 3 | NCT02579265 | Dec 2015 → Apr 2020 | — | Fresenius Kabi | Terminated | No outcome recorded |
| Phase 3 | NCT02663453 | Dec 2013 → Dec 2015 | cholestasis | Thammasat University | Completed | No outcome recorded |
| Phase 3 | NCT02760472 | Mar 2013 → Sep 2015 | retinopathy of prematurity | Carola Pfeiffer-Mosesson | Completed | No outcome recorded |
| Phase 3 | NCT00451646 | Oct 2007 → Oct 2008 | — | Fresenius Kabi | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT06049680 | Oct 2024 → Aug 2026 overdue | metabolic disease, nutritional deficiency disease, parenteral nutrition-associated cholestasis | Fresenius Kabi | Recruiting | No outcome recorded |
| Phase 4 | NCT04277923 | Feb 2020 → Aug 2021 | pulmonary immaturity | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT03563222 | Dec 2019 → Nov 2020 | protein-energy malnutrition | Fresenius Kabi | Terminated | No outcome recorded |
| Phase 4 | NCT03857646 | Mar 2019 → Jun 2020 | — | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT03054948 | Feb 2017 → Mar 2018 | short bowel syndrome | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 4 | NCT02796833 | Mar 2016 → Dec 2019 | parenteral nutrition-associated cholestasis | Johane Allard | Completed | No outcome recorded |
| Phase 4 | NCT04347902 | Jan 2016 → Mar 2020 | intestinal failure–associated liver disease, liver failure | Stanley Dudrick's Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02539316 | Jun 2015 → Oct 2016 | — | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 4 | NCT01585935 | Jun 2012 → Jun 2015 | cholestasis, neurodevelopmental disorder | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT03149653 | Jan 2012 → Jan 2016 | — | General University Hospital, Prague | Completed | No outcome recorded |
| Phase 4 | NCT03044639 | Apr 2010 → Oct 2016 | liver failure | Stanley Dudrick's Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00885781 | Nov 2008 → Apr 2009 | nutritional disorder | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00600912 | Dec 2006 → Dec 2007 | inflammatory disease | Klinikum Ludwigshafen | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04951791 | Aug 2021 → Aug 2023 | ischemic disease | Assiut University | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02412566 | — | cholestasis | Baylor College of Medicine | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03275090 Comparator | Feb 2016 → Jan 2017 | neonatal sepsis | Mansoura University Children Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02544919 Comparator | Sep 2015 → Sep 2017 | — | Mansoura University | Unknown | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SMOFlipid | “The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a...” NCT02539316 ↗29“The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term...” NCT00451646 ↗ “Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n-3 FA, and vitamin E status in premature infants requiring PN.” PMID 20531018 ↗ Oct 2010 “Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)” NCT04347902 ↗ “Drs. Guirgis and Henson disclosed off-label use of SMOFlipid (Fresenius Kabi, Lake Zurich, IL).” PMID 38488429 ↗ Mar 2024 “Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid” NCT03857646 ↗ “SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)” NCT03044639 ↗ “SMOF lipid (SMOFLIPID) pre treatment” NCT02544919 ↗ “SMOFlipid” NCT00885781 ↗ |
| Known as | lipid injectable emulsion with Fish oil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04031508 ↗ |
| Known as | SMOF | “SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)” NCT03044639 ↗ |
| Known as | SMOFLIPID (mixture of soy, fish, MCT and olive oil) | “SMOFLIPID (mixture of soy, fish, MCT and olive oil)” NCT01585935 ↗ |
| Known as | SMOFlipid 20% (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany) | “SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany)” NCT00600912 ↗ |
| Known as | Smoflipid 20% (lipid injectable emulsion) | “Smoflipid 20% (lipid injectable emulsion)” NCT02579265 ↗ |
| Known as | Smoflipid Lipid Injectible Emulsion, USP 20% | “Smoflipid® Lipid Injectible Emulsion, USP 20%” NCT03563222 ↗ |
| Modality | Other / unclassified | “new lipid emulsion based ob soybean oil, medium-chain triglycerides, olive oil and fish oil” NCT00600912 ↗ |
| Route | Intravenous | “Fat Emulsions for Intravenous Nutrition” NCT00793195 ↗ |