Drugs / Omegaven
last change Sep 2023 re-read 9 days ago

Omegaven

Other / unclassified

Developed for
parenteral nutrition-associated cholestasis · liver disorder · cholestasis · short bowel syndrome · intestinal failure–associated liver disease · acute myeloid leukemia · cancer · cirrhosis of liver
+13 more · critical illness polyneuropathy · disease related to hematopoietic stem cell transplant · esophageal atresia · gastric neoplasm · hepatobiliary disorder · liver cancer · neoplasm of esophagus · retinopathy of prematurity · rheumatoid arthritis · ventricular tachycardia · atrial fibrillation · COVID-19 · Crohn disease
Investigated by
Boston Children's Hospital · Jagiellonian University · University of California, San Diego · University of Nebraska · Wake Forest University Health Sciences · Aalborg University Hospital
+43 more · Alexandra N. Carey · Amarnath, Rathna, M.D. · Arthur J De Lorimier · Assistance Publique - Hôpitaux de Paris · Baylor College of Medicine · Carle Foundation Hospital · Catherine Cibulskis, MD · Charles University, Czech Republic · Children's Hospital Los Angeles · Children's Hospital Medical Center, Cincinnati · Children's Hospital and Medical Center, Omaha, Nebraska · Children's Hospital of Philadelphia · Children's Medical Center Dallas · Children's Mercy Hospital Kansas City · Cindy Haller · Cook Children's Health Care System · Ege University · French Innovative Leukemia Organisation · Fresenius Kabi · General University Hospital, Prague · Georgetown University · Huazhong University of Science and Technology · Humanis Klinikum Niederosterreich · Mark Puder · Midwestern Regional Medical Center · Ministry of Health, Czech Republic · National Taiwan University Hospital · Northwell Health · OU Medical Center · Pediatrix · Rush University Medical Center · Sivan Kinberg · St. Louis University · St. Luke's Health System, Boise, Idaho · The Hartwell Foundation · The University of Texas Health Science Center at San Antonio · University Hospitals, Leicester · University of California, Los Angeles · University of Oklahoma · University of Pittsburgh · University of Pittsburgh · University of South Florida · Vanderbilt University Medical Center

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) OMEGAVEN — 2018-07-27 fda.gov ↗

Trials 46

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02512718 Jun 2016 → May 2023 disease related to hematopoietic stem cell transplant Alexandra N. Carey Completed No outcome recorded
Phase 1 NCT00512629 Jul 2007 → Dec 2011 parenteral nutrition-associated cholestasis Boston Children's Hospital Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT01601652 Nov 2011 → Dec 2018 parenteral nutrition-associated cholestasis Arthur J De Lorimier Completed No outcome recorded
Phase 1/2 NCT00534300 Oct 2007 → Jun 2008 sudden cardiac arrest, ventricular tachycardia Aalborg University Hospital Completed No outcome recorded
Phase 210 trials · 1 met primary · 1 missed
Phase 2 NCT03127345 Sep 2019 → Sep 2023 esophageal atresia Boston Children's Hospital Withdrawn No outcome recorded Stop: Business
Phase 2 NCT02486042 Mar 2014 → Dec 2019 retinopathy of prematurity University of California, San Diego Completed Mixed
Phase 2 NCT01999413 Nov 2013 → Mar 2016 acute myeloid leukemia French Innovative Leukemia Organisation Completed Missed primary
Phase 2 NCT01325584 Oct 2012 → Dec 2016 cancer, liver disorder Midwestern Regional Medical Center Terminated No outcome recorded
Phase 2 NCT01870791 May 2012 → Dec 2015 gastric neoplasm, neoplasm of esophagus University Hospitals, Leicester Terminated No outcome recorded
Phase 2 NCT01845116 Jul 2010 → Jul 2020 parenteral nutrition-associated cholestasis Wake Forest University Health Sciences Completed No outcome recorded
Phase 2 NCT00969332 Aug 2009 → Jan 2019 cholestasis University of California, Los Angeles Terminated Met primary
Phase 2 NCT00826020 May 2009 → Oct 2017 cholestasis, intestinal failure–associated liver disease University of Nebraska Completed No outcome recorded
Phase 2 NCT01739517 Mar 2009 → Dec 2013 cholestasis, short bowel syndrome Amarnath, Rathna, M.D. Unknown No outcome recorded
Phase 2 NCT00816348 Dec 2008 → Feb 2014 parenteral nutrition-associated cholestasis Cindy Haller Terminated No outcome recorded
Phase 2/33 trials · 1 met primary
Phase 2/3 NCT02370251 Jun 2015 → Sep 2018 gastroschisis, intestinal atresia, parenteral nutrition-associated cholestasis, short bowel syndrome University of Oklahoma Completed No outcome recorded
Phase 2/3 NCT04697888 Apr 2013 → Nov 2018 hepatobiliary disorder Children's Mercy Hospital Kansas City Completed No outcome recorded
Phase 2/3 NCT00910104 Aug 2006 → Jan 2019 liver disorder, short bowel syndrome Mark Puder Completed Met primary
Phase 32 trials
Phase 3 NCT03662282 Oct 2018 → Jan 2019 parenteral nutrition-associated cholestasis University of South Florida Completed No outcome recorded
Phase 3 NCT00412256 Sep 2004 → Nov 2006 rheumatoid arthritis Humanis Klinikum Niederosterreich Completed No outcome recorded
Phase 46 trials · 1 missed
Phase 4 NCT03149653 Jan 2012 → Jan 2016 — General University Hospital, Prague Completed No outcome recorded
Phase 4 NCT02321202 Mar 2010 → Sep 2013 cirrhosis of liver, liver cancer Huazhong University of Science and Technology Completed No outcome recorded
Phase 4 NCT00862446 Mar 2009 → Oct 2019 liver disorder Vanderbilt University Medical Center Completed No outcome recorded
Phase 4 NCT00172198 Mar 2005 → Mar 2007 critical illness polyneuropathy National Taiwan University Hospital Unknown No outcome recorded
Phase 4 NCT00732849 Jun → Sep 2002 — Jagiellonian University Completed No outcome recorded
Phase 4 NCT00558155 Jun 2001 → Dec 2005 gastric cancer, malignant pancreatic neoplasm Jagiellonian University Completed Missed primary
Phase not applicable8 trials
— NCT02334293 Oct 2013 → Jul 2017 cholestasis Carle Foundation Hospital Unknown No outcome recorded
— NCT02010034 Aug 2013 → Feb 2019 liver disorder Children's Medical Center Dallas Completed No outcome recorded
— NCT01284049 Nov 2011 → Apr 2015 liver disorder Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
— NCT01323907 Jan 2011 → Feb 2019 parenteral nutrition-associated cholestasis Sivan Kinberg Withdrawn No outcome recorded
— NCT01173159 Jul 2010 → Dec 2018 cholestasis Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
— NCT00738101 Sep 2008 → Mar 2019 parenteral nutrition-associated cholestasis Baylor College of Medicine Completed No outcome recorded
— NCT01089426 Sep 2008 → Apr 2019 liver disorder Children's Hospital Los Angeles Completed No outcome recorded
— NCT00929461 — — Ege University Completed No outcome recorded
Phase not stated13 trials
— NCT02929303 — parenteral nutrition-associated cholestasis Wake Forest University Health Sciences Approved for marketing No outcome recorded
— NCT02534077 — parenteral nutrition-associated cholestasis Pediatrix Approved for marketing No outcome recorded
— NCT01861834 — parenteral nutrition-associated cholestasis Georgetown University Approved for marketing No outcome recorded
— NCT02148146 — cholestasis University of California, San Diego No longer available No outcome recorded
— NCT01412359 — parenteral nutrition-associated cholestasis University of Pittsburgh Approved for marketing No outcome recorded
— NCT01425567 — liver disorder The University of Texas Health Science Center at San Antonio Approved for marketing No outcome recorded
— NCT02121769 — liver disorder St. Luke's Health System, Boise, Idaho No longer available No outcome recorded
— NCT02925520 — liver disorder Cook Children's Health Care System No longer available No outcome recorded
— NCT02477345 — cholestasis, liver disorder Northwell Health No longer available No outcome recorded
— NCT01297933 — cholestasis, short bowel syndrome Children's Hospital of Philadelphia Approved for marketing No outcome recorded
Comparator or background therapy5 trials
Phase 2 NCT04647604 Comparator Jun 2020 → Jan 2021 COVID-19 Karolinska University Hospital Completed No outcome recorded
Phase 3 NCT01884948 Comparator Jul 2013 → Mar 2016 — University of Zurich Unknown No outcome recorded
Phase 3 NCT01175330 Comparator Aug 2010 → Dec 2012 atrial fibrillation, ischemic disease Meshalkin Research Institute of Pathology of Circulation Terminated No outcome recorded
Phase 4 NCT02231203 Comparator Oct 2014 → Jun 2016 colon carcinoma Medical Center Alkmaar Completed No outcome recorded
Phase 4 NCT02349594 Comparator Jan 2014 → May 2015 Crohn disease Radboud University Medical Center Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 52 sources stand behind the page.

FieldValueCited text
Known as Omegaven “In a published article (Gura, Duggan et al. 2006) reporting 2 cases in depth and in a subsequent paper (Gura, Lee et al. 2008) reporting 18 patients with established PNALD who...” NCT03072667 ↗
52

“In the omega-3 group, the lipid content of TPN was replaced partially by omega-3 fatty acids (Omegaven®, Fresenius-Kabi) up to 0.2 g/kg BW per day.” NCT00929461 ↗

“10% n-3 fatty acid (Omegaven, Fresenius-Kabi, Germany)” PMID 27614675 ↗ Aug 2016

“started on Omegaven®” NCT01425567 ↗

NCT01412359 ↗

NCT00732849 ↗

NCT00969332 ↗

NCT04647604 ↗

NCT01601652 ↗

NCT02231203 ↗

NCT01173159 ↗

Show 42 more sources

Known as fish oil “The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated...” NCT00969332 ↗
Known as fish oil infusion “This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to...” NCT02929303 ↗
Known as FOLE “The experimental group will receive FOLE (Omegaven®, Fresenius Kabi AG, Bad Homburg v.d.h., Germany), a 10% lipid solution.” NCT02512718 ↗
Known as omega-3 fatty acids “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven) on outcome after major liver resection” NCT01884948 ↗
Known as Omega-3 fish oil emulsion “Omega-3 fish oil emulsion (Omegaven)” NCT01175330 ↗
Known as OMEGAVEN 10% “OMEGAVEN 10%® will be used as the sole lipid supplement at a dose of 0.5 to 1.0 g/kg/Infusion with a maximum dose per infusion of 40 grams, in view of formulation constraints...” NCT01284049 ↗
Known as Ω3-FAs “2 single intravenous infusions of Omegaven® (Ω3-FAs) vs. placebo” PMID 31626819 ↗ Oct 2019
Modality Other / unclassified “fish-oil preparation (Omegaven)” NCT00412256 ↗
Route Other “parenterally applied fat emulsions” NCT00412256 ↗