Compassionate Use of Omegaven IV Fat Emulsion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323907
Recruitment Status : Enrolling by invitation
First Posted : March 28, 2011
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
Sivan Kinberg, Columbia University

March 16, 2011
March 28, 2011
July 21, 2017
January 2011
January 2019   (Final data collection date for primary outcome measure)
Reduction of direct serum bilirubin level (mg/dL) [ Time Frame: Up to 6 months from the completion of the study. ]
For effectiveness endpoint, the allowable minimum time interval between serial direct bilirubin measurements that will determine reversal of cholestasis is 2 consecutive measurements of direct bilirubin < or = to 2mg/dL obtained at least 2 weeks apart.
Same as current
Complete list of historical versions of study NCT01323907 on Archive Site
Essential fatty acid profile [ Time Frame: Up to 30 days from therapy completion ]
Previous studies have found no association between Omegaven administration and essential fatty acid deficiency. Due to theoretical concern for developing fatty acid deficiency with low dose Omegaven administration, these levels will be followed during Omegaven therapy.
Same as current
Not Provided
Not Provided
Compassionate Use of Omegaven IV Fat Emulsion
Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Total Parenteral Nutrition-induced Cholestasis
Drug: Omegaven IV lipid emulsion
For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition.
Other Name: Omega-3 Fatty Acids
Experimental: Omegaven
Omegaven IV lipid emulsion administration for infants with life threatening parenteral nutrition associated liver disease
Intervention: Drug: Omegaven IV lipid emulsion
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
Same as current
January 2019
January 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of life threatening PNALD
  • Dependent on Parenteral Nutrition for caloric needs
  • Expected to require PN for at least another 30 days
  • Other causes of liver disease have been excluded
  • GI/Liver service is involved in patient care
  • Standard therapies for the treatment of PNALD must have been utilized prior to initiating omegaven.
  • Inpatient at Morgan Stanley Children's Hospital of NewYork Presbyterian Hospital
  • Must be at least 2 months of age

Exclusion Criteria:

  • Not inpatient
  • Younger than 2 months of age
  • Expected to be weaned off of parenteral nutrition within 30 days
  • have other documented causes of liver disease
  • have signs of proven severe advanced liver disease
  • Allergy to seafood, egg protein and/or previous allergy to Omegaven
  • active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI, cholestasis due to any reason other than PNALD, active new infection at time of initiation of Omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring
  • must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians).
  • Parent or legal guardian must be willing to provide consent.
Sexes Eligible for Study: All
2 Months to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Sivan Kinberg, Columbia University
Sivan Kinberg
Not Provided
Principal Investigator: Sivan Kinberg, MD, MS Columbia University
Columbia University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP