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Compassionate Use of Omegaven IV Fat Emulsion

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ClinicalTrials.gov Identifier: NCT00816348
Recruitment Status : Terminated
First Posted : January 1, 2009
Results First Posted : February 9, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Cindy Haller, Northwell Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cholestasis
Total Parenteral Nutrition-induced Cholestasis
Intervention Drug: Omegaven
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omegaven
Hide Arm/Group Description

All subjects will receive Omegaven

Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/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 either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.

Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Omegaven
Hide Arm/Group Description

All subjects will receive Omegaven

Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/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 either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
15
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 15 participants
89.3
(35 to 306)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
bilirubin level  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 15 participants
6.79  (4.14)
1.Primary Outcome
Title Level of Bilirubin
Hide Description measurement of bilirubin level weekly. Available data reported.
Time Frame week 2, 3,4,and 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omegaven
Hide Arm/Group Description:

All subjects will receive Omegaven

Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/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 either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 2 N=12 7.4  (4.38)
Week 3 N=8 6.63  (4.39)
Week 4 N=10 7.97  (6.5)
Week 8 N=11 4.72  (4.81)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omegaven
Hide Arm/Group Description

All subjects will receive Omegaven

Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/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 either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.

All-Cause Mortality
Omegaven
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Omegaven
Affected / at Risk (%)
Total   1/15 (6.67%) 
Cardiac disorders   
death *  1/15 (6.67%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omegaven
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Cindy Haller MD
Organization: NSLIJ Health System
Phone: 516-472-3650
Responsible Party: Cindy Haller, Northwell Health
ClinicalTrials.gov Identifier: NCT00816348     History of Changes
Other Study ID Numbers: 08-204
First Submitted: December 31, 2008
First Posted: January 1, 2009
Results First Submitted: August 7, 2015
Results First Posted: February 9, 2016
Last Update Posted: March 10, 2017