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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR OMEGAVEN

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Clinical Trials for Omegaven

Trial ID Title Status Sponsor Phase Summary
NCT00172198 Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU. Unknown status National Taiwan University Hospital Phase 4 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 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 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 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 Summary

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Clinical Trial Conditions for Omegaven

Condition Name

Condition Name for Omegaven
Intervention Trials
Cholestasis 17
Total Parenteral Nutrition-induced Cholestasis 10
Short Bowel Syndrome 4
Cholestasis of Parenteral Nutrition 4
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Condition MeSH

Condition MeSH for Omegaven
Intervention Trials
Cholestasis 27
Liver Diseases 14
Short Bowel Syndrome 5
Wounds and Injuries 2
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Clinical Trial Locations for Omegaven

Trials by Country

Trials by Country for Omegaven
Location Trials
United States 34
Canada 3
China 3
Taiwan 2
Netherlands 2
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Trials by US State

Trials by US State for Omegaven
Location Trials
Texas 6
California 5
Illinois 4
New York 3
Massachusetts 2
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Clinical Trial Progress for Omegaven

Clinical Trial Phase

Clinical Trial Phase for Omegaven
Clinical Trial Phase Trials
Phase 4 8
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Omegaven
Clinical Trial Phase Trials
Recruiting 13
Completed 11
Available 7
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Clinical Trial Sponsors for Omegaven

Sponsor Name

Sponsor Name for Omegaven
Sponsor Trials
Fresenius Kabi 3
Boston Children’s Hospital 3
Baylor College of Medicine 2
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Sponsor Type

Sponsor Type for Omegaven
Sponsor Trials
Other 62
Industry 5
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