19 completed, 8 approved for marketing, 5 terminated, 3 no longer available. 14 Phase 2, 6 Phase 3, 4 Not applicable, 4 Phase 1, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 7, Terminated 5, Unknown 1, Withdrawn 1 |
| Phase 3 | 6 | Completed 5, Unknown 1 |
| Not applicable | 4 | Completed 3, Unknown 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 4 | 3 | Completed 3 |
Follow Omegaven: new trials by email Literature Review of Omegaven trials Research Report on Omegaven
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 |
|---|---|---|---|---|---|---|
| High Dose Intravenous Fish Oil Reduces Inflammation Omegaven - Lipid Metabolism Disorders | Completed | Stanley Dudrick's Memorial Hospital | 51 | 2020-01-31 | 2020-07-22 | |
| Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health Omegaven, Intralipid - Esophageal Atresia | Phase 2 | Withdrawn | Boston Children's Hospital | 2019-09-01 | 2019-09-16 | |
| Omegaven as Alternative Parenteral Fat Nutrition Omegaven - Cholestasis, Cholestasis of Parenteral Nutrition | Phase 3 | Completed | University of South Florida | 2 | 2018-10-23 | 2020-07-22 |
| Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation Omegaven, Soybean oil lipid emulsion - Hematopoietic Stem Cell Transplantation | Phase 1 | Completed | Alexandra N. Carey | 20 | 2016-06-01 | 2025-09-22 |
| Compassionate Use of Omegaven in Children Omegaven - Total Parenteral Nutrition-induced Cholestasis, Cholestasis | Phase 2 / Phase 3 | Completed | University of Oklahoma | 63 | 2015-06-01 | 2019-11-25 |
| Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function Omegaven, Placebo - Colon Cancer | Phase 4 | Completed | Medical Center Alkmaar | 44 | 2014-10-01 | 2018-07-31 |
| Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity Omegaven, Standard lipids (primarily omega-6 fatty acids) - Retinopathy of Prematurity | Phase 2 | Completed | University of California, San Diego | 48 | 2014-03-01 | 2022-12-29 |
| Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients OMEGAVEN, Daunorubicin, Cytarabine - Acute Myeloid Leukemia (AML) | Phase 2 | Completed | French Innovative Leukemia Organisation | 30 | 2013-11-01 | 2018-04-27 |
| Omegaven® as Parenteral Nutrition Omegaven - Cholestasis | Not applicable | Unknown | Carle Foundation Hospital | 25 | 2013-10-01 | 2015-01-08 |
| Fish OIL Optimal dosE Determination Study 0.20 gm/kg fish oil, 0.50 gm/kg fish oil - Sepsis | Phase 2 | Terminated | University Hospital Carl Gustav Carus | 7 | 2013-10-01 | 2017-04-19 |
| Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury Omegaven - Liver Disease, Impaired Liver Function | Not applicable | Completed | Children's Medical Center Dallas | 15 | 2013-08-01 | 2019-02-06 |
| Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease Omegaven - Parenteral Nutrition-related Hepatitis | Phase 2 / Phase 3 | Completed | Children's Mercy Hospital Kansas City | 2 | 2013-04-01 | 2021-06-11 |
| Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury Omegaven - Cancer, Hepatic Injury | Phase 2 | Terminated | Midwestern Regional Medical Center | 12 | 2012-10-01 | 2018-08-07 |
| Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer Omegaven - Esophageal Neoplasm, Gastric Neoplasm | Phase 2 | Terminated | University Hospitals, Leicester | 21 | 2012-05-01 | 2016-05-26 |
| Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis Omegaven - Parenteral Nutrition Associated Cholestasis | Phase 1 / Phase 2 | Completed | Arthur J De Lorimier | 12 | 2011-11-01 | 2021-01-27 |
| Minimization of IntraLipid Versus Omegaven Omegaven, Lipid minimization - Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD) | Phase 2 / Phase 3 | Unknown | Children's & Women's Health Centre of British Columbia | 40 | 2010-12-01 | 2011-09-07 |
| Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children Omega-3 fish oil lipid emulsion - Cholestasis | Phase 3 | Completed | Kapiolani Medical Center For Women & Children | 36 | 2010-10-20 | 2026-04-03 |
| Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis Omegaven - Cholestasis | Not applicable | Completed | Children's Hospital Medical Center, Cincinnati | 10 | 2010-07-01 | 2020-06-17 |
| A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease Omegaven - Cholestasis | Phase 2 | Terminated | University of California, Los Angeles | 62 | 2009-08-01 | 2020-02-26 |
| Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease Omegaven - Parenteral Nutrition Associated Liver Disease | Phase 4 | Completed | Vanderbilt University Medical Center | 48 | 2009-03-01 | 2021-01-05 |
Showing 20 of 38. Sign in to see all of them.
Cholestasis (20) · Hyperphagia (8) · Short Bowel Syndrome (6) · Liver Diseases (5) · Intestinal Atresia (2) · Intestinal Failure (2) · Premature Birth (2) · Sepsis (2) · Adenocarcinoma Of Esophagus (1) · Colitis (1) · Colonic Neoplasms (1) · Death, Sudden, Cardiac (1) · Esophageal Atresia (1) · Esophageal Neoplasms (1) · Gastroschisis (1)
Boston Children's Hospital (2) · University of California, San Diego (2) · Aalborg University Hospital (1) · Alexandra N. Carey (1) · Arthur J De Lorimier (1) · Baylor College of Medicine (1) · Carle Foundation Hospital (1) · Catherine Cibulskis, MD (1) · Children's & Women's Health Centre of British Columbia (1) · Children's Hospital Medical Center, Cincinnati (1) · Children's Hospital of Philadelphia (1) · Children's Medical Center Dallas (1) · Children's Mercy Hospital Kansas City (1) · Cindy Haller (1) · Cook Children's Health Care System (1)
United States (25) · Canada (1) · China (1) · Denmark (1) · France (1) · Germany (1) · Netherlands (1) · Poland (1) · Switzerland (1) · Taiwan (1) · United Kingdom (1)
Alexandra N Carey, MD (1) · Aloka L Patel, MD (1) · Avash J Singh, MD (1) · Axel R. Heller, MD (1) · Bankole O Osuntokun, MD, MS (1) · Boon-Siang Khor, MD (1) · Brian A Jones, MD (1) · Christopher Duggan, MD, MPH (1) · Cindy Haller, MD (1) · Cynthia Blanco, MD (1) · Daren Heyland, MD, PhD (1) · David J Bowrey, MD (1) · Edward A Everett, DO (1)
PMID 20473991, PMID 23164314, PMID 23770843, PMID 23894176, PMID 23909727, PMID 27342748, PMID 28437326, PMID 28521607, PMID 29505137, PMID 29960156, PMID 30142422, PMID 30411372, PMID 30900274, PMID 31826232, PMID 32059815, PMID 32072161, PMID 33038344, PMID 34695449, PMID 35697729