14 completed, 5 unknown, 4 terminated, 2 withdrawn. 12 Phase 4, 7 Not applicable, 4 Phase 3, 3 Phase 1, 3 Phase 2.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| First-in-Human Safety and Tolerability Study of OPF-110 in Healthy Adults OPF-110, SMOFLIPID - Healthy Volunteers | Phase 1 | Active not recruiting | Otsuka Pharmaceutical Factory, Inc. | 24 | 2026-08-12 | 2026-10-19 |
| Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients SMOFlipid® (lipid injectable emulsion) - Malnutrition, Child, Malnutrition | Phase 4 | Recruiting | Fresenius Kabi | 100 | 2024-10-28 | 2026-10-22 |
| Lipid Emulsion in Cardiac Valve Replacement Surgery SMOFlipid, Normal saline 0.9% - Ischemic Reperfusion Injury | Not applicable | Unknown | Assiut University | 68 | 2021-08-01 | 2021-07-07 |
| Lipid Emulsion Infusion and COVID-19 Patients SMOFlipid, 0.9% saline - Covid19 | Phase 3 | Completed | Assiut University | 74 | 2021-07-05 | 2021-09-28 |
| Effects of Parenteral Nutrition in HSCT Glucose/Amino acids, Glucose/Amino acids/Lipids - Hematologic Malignancy | Not applicable | Completed | St. Petersburg State Pavlov Medical University | 120 | 2020-02-01 | 2021-06-24 |
| Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants SMOFlipid, Lipofundin - Preterm Infant | Phase 4 | Unknown | Shanghai Jiao Tong University School of Medicine | 66 | 2020-02-01 | 2020-02-20 |
| Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Smoflipid, Intralipid, 20% - Malnutrition, Child | Phase 4 | Terminated | Fresenius Kabi | 1 | 2019-12-18 | 2022-12-12 |
| SMOFlipid and Incidence of BPD in Preterm Infants n3-LCPUFA enriched Intravenous Lipid Emulsion - Very Low Birth Weight Infant, Bronchopulmonary Dysplasia | Not applicable | Unknown | University of Calgary | 384 | 2019-12-16 | 2022-11-07 |
| Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH lipid injectable emulsion with Fish oil - Pulmonary Hypertension of Newborn, Diaphragm Defect | Phase 2 | Enrolling by invitation | Coordinación de Investigación en Salud, Mexico | 40 | 2019-08-12 | 2026-03-18 |
| White Test in Intra-operative Detection of Donor Biliary Leak in LDLTx. The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage., Saline test (routine test) - Bile Leak | Not applicable | Completed | Amr Abdelaal | 60 | 2019-03-20 | 2020-06-30 |
| Intralipid Versus SMOFlipid in HPN Patients SMOFLipid, Intralipid - Short Bowel Syndrome, Intestinal Fistula | Not applicable | Completed | Mayo Clinic | 22 | 2018-12-31 | 2025-05-16 |
| Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion - Cholestasis of Parenteral Nutrition | Phase 3 | Completed | Indiana University | 24 | 2018-11-30 | 2025-07-30 |
| LIPIDS-P Trial Phase I/II Trial Smoflipid - Sepsis, Severe, Septic Shock | Phase 1 / Phase 2 | Completed | University of Florida | 59 | 2018-08-17 | 2025-08-11 |
| SMOFLipid in Patients Who Are Intralipid Intolerant SMOFLipid, Standard therapy - Home Parenteral Nutrition, Short Bowel Syndrome | Phase 4 | Withdrawn | Mayo Clinic | 2017-02-01 | 2018-03-22 | |
| Rate of Bronchopulmonary Dysplasia in Preterms Neonates: a Trial Comparing SMOFlipid and Medialipide SMOFlipid®, Medialipide® - Preterm Neonates | Phase 4 | Withdrawn | Hospices Civils de Lyon | 2017-01-01 | 2019-07-24 | |
| SMOFlipid to Lessen the Severity of Neonatal Cholestasis SMOFlipid - Cholestasis, Jaundice, Obstructive | Phase 1 / Phase 2 | Terminated | University of Florida | 2 | 2016-05-01 | 2017-04-17 |
| The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis Smoflipid ® - Sepsis Newborn | Phase 4 | Completed | Mansoura University Children Hospital | 40 | 2016-02-01 | 2018-03-23 |
| Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20% - Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days | Phase 3 | Terminated | Fresenius Kabi | 204 | 2015-12-01 | 2022-01-05 |
| Lipids and Neurological Complications in Liver Transplantation SMOF lipid (SMOFLIPID) pre treatment - Neurological Complications | Phase 4 | Unknown | Mansoura University | 80 | 2015-09-01 | 2017-03-27 |
| Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population Smoflipid, Médialipides - Dietary and Nutritional Therapies | Phase 4 | Completed | Centre Hospitalier Universitaire de Nice | 9 | 2015-06-01 | 2017-04-13 |
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Hyperphagia (11) · Cholestasis (3) · Premature Birth (3) · Child Nutrition Disorders (2) · Intestinal Failure (2) · Malnutrition (2) · Retinopathy of Prematurity (2) · Sepsis (2) · Short Bowel Syndrome (2) · Bronchopulmonary Dysplasia (1) · COVID-19 (1) · Cholestasis, Intrahepatic (1) · Crohn Disease (1) · End Stage Liver Disease (1) · Enterocolitis, Necrotizing (1)
Fresenius Kabi (3) · Assiut University (2) · Mansoura University (2) · Mayo Clinic (2) · University of Florida (2) · Amr Abdelaal (1) · Baylor College of Medicine (1) · Carola Pfeiffer-Mosesson (1) · Centre Hospitalier Universitaire de Nice (1) · Centro Hospitalar de Lisboa Central (1) · Chang Gung Memorial Hospital (1) · Coordinación de Investigación en Salud, Mexico (1) · Dr. Sami Ulus Children's Hospital (1) · General University Hospital, Prague (1) · Hospices Civils de Lyon (1)
United States (10) · Egypt (5) · France (2) · Austria (1) · Canada (1) · Czechia (1) · Germany (1) · Mexico (1) · Russia (1) · Taiwan (1) · Turkey (Türkiye) (1)
Amr M Yassen, MD (2) · Jeffrey Rudolph, MD (2) · Alexander Kulagin, Professor (1) · Andreas Repa, MD (1) · Belal Alshaikh, MD, MSc (1) · Carola Pfeiffer-Mosesson, RN (1) · Chih-Che Lin, MD (1) · Faheem W Guirgis, MD (1) · Frantisek Novak, MD, PhD (1) · Josef Neu, MD (1) · Luis Pereira-da-Silva, MD, PhD (1) · Manpreet S Mundi (1) · Manpreet S Mundi, MD (1) · Mariela Bernabe-Garcia, Ph.D. (1) · Muralidhar H. Premkumar, MD (1)
PMID 20393276, PMID 10022591, PMID 10670636, PMID 11303131, PMID 11544428, PMID 11895160, PMID 11906641, PMID 12480795, PMID 12710654, PMID 15269615, PMID 15585684, PMID 16254497, PMID 16582962, PMID 16632649, PMID 17261965, PMID 18310188, PMID 18570946, PMID 19571170, PMID 19687773, PMID 19702523, PMID 19840246, PMID 20085628, PMID 20116213, PMID 20398379, PMID 20852178, PMID 21199856, PMID 21621696, PMID 22319539, PMID 22683686, PMID 22796064, PMID 22942104, PMID 23155344, PMID 23398476, PMID 24961544, PMID 25722954, PMID 25755385, PMID 25879776, PMID 26146621, PMID 26630252, PMID 26791189, PMID 28244792, PMID 28630687, PMID 29035319, PMID 29269199, PMID 29415837, PMID 29423508, PMID 30297879, PMID 31030946, PMID 31537565, PMID 32588218
2008 (1)