CLINICAL TRIALS PROFILE FOR OMEGAVEN
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All Clinical Trials for OMEGAVEN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00172198 ↗ | Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU. | Unknown status | National Taiwan University Hospital | Phase 4 | 2005-03-01 | 1. A prospective, controlled, randomized, study evaluating the clinical efficacy, including nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented parenteral nutrition in subjects of SICU. 2. Study patients are the critical ill patients in SICU of NTUH and the enrolled patients will be 30 subjects ,including 15 in each treatment group. 3. During parenteral nutrition, fat emulsions will be given separately from amino acid and glucose solutions. Infusion pump must be used.The recommended infusion duration of the daily lipid emulsion is 16 hours (0.0625 g fat/kg B.W./hour) from 8:00 am to 12:00 pm. 4. During the study the assessments of safety and efficacy are to be performed according to case report form. The assessment for safety variables including blood pressure、heat rate 、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In addition，the assessments for efficacy variables including lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40 ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital stay、mortality etc. |
| NCT00292279 ↗ | The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients | Completed | Sino-Swed Pharmaceutical Corporation | Phase 3 | 2002-06-01 | The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil emulsion on outcome in post-operative cancer patients. |
| NCT00412256 ↗ | Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial) | Completed | Humanis Klinikum Niederosterreich | Phase 3 | 2004-09-01 | The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with active rheumatoid arthritis. |
| NCT00512629 ↗ | Cholestasis Prevention: Efficacy of IV Fish Oil | Completed | Boston Children's Hospital | Phase 1 | 2007-07-01 | Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a murine model, we observed that intravenous fat emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of cholestasis, a common precursor of PN-associated liver disease, as well as reverse preexisting PNALD through a combination of factors, including improved triglyceride clearance coupled with anti-inflammatory properties. In a case series treating patients with hepatic cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no adverse reactions attributed to its use were observed. Based on results of these previous studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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