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Compassionate Use of Omegaven IV Fat Emulsion

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816348
First Posted: January 1, 2009
Last Update Posted: March 10, 2017
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.
Information provided by (Responsible Party):
Cindy Haller, Northwell Health
Results First Submitted: August 7, 2015  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Omegaven

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.


Participant Flow:   Overall Study
    Omegaven
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Omegaven

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.


Baseline Measures
   Omegaven 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      15 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Days]
Mean (Full Range)
 89.3 
 (35 to 306) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  66.7% 
Male      5  33.3% 
Region of Enrollment 
[Units: Participants]
 
United States   15 
bilirubin level 
[Units: mg/dL]
Mean (Standard Deviation)
 6.79  (4.14) 


  Outcome Measures

1.  Primary:   Level of Bilirubin   [ Time Frame: week 2, 3,4,and 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: challer@lij.edu



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