Compassionate Use of Omegaven IV Fat Emulsion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Christiana Farkouh-Karoleski, Columbia University
ClinicalTrials.gov Identifier:
NCT01323907
First received: March 16, 2011
Last updated: February 11, 2013
Last verified: February 2013

March 16, 2011
February 11, 2013
January 2011
January 2015   (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. ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Essential fatty acid profile [ Time Frame: Up to 30 days from therapy completion ] [ Designated as safety issue: Yes ]
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 infants 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
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
January 2015
January 2015   (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.
  • Under the care of an attending Neonatologist in the NICU
  • Must be at least 2 months of age

Exclusion Criteria:

  • Not a NICU patient
  • 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.
Both
2 Months to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01323907
AAAF2546
Yes
Christiana Farkouh-Karoleski, Columbia University
Christiana Farkouh-Karoleski
Not Provided
Principal Investigator: Chrsitiana R Farkouh, MD, MPH Columbia University
Columbia University
February 2013

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