Trial Outcomes & Findings for Compassionate Use of Omegaven IV Fat Emulsion (NCT NCT00816348)

Last Updated: 2017-03-10

Results Overview

measurement of bilirubin level weekly. Available data reported.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

week 2, 3,4,and 8

Results posted on

2017-03-10

Participant milestones
Measure	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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Compassionate Use of Omegaven IV Fat Emulsion

Baseline characteristics by cohort
Measure	Omegaven n=15 Participants 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.
Age, Categorical <=18 years	15 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	89.3 days n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Region of Enrollment United States	15 participants n=93 Participants
bilirubin level	6.79 mg/dL STANDARD_DEVIATION 4.14 • n=93 Participants

Timeframe: week 2, 3,4,and 8

measurement of bilirubin level weekly. Available data reported.

Outcome measures
Measure	Omegaven n=15 Participants 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.
Level of Bilirubin Week 2 N=12	7.4 mg/dL Standard Deviation 4.38
Level of Bilirubin Week 3 N=8	6.63 mg/dL Standard Deviation 4.39
Level of Bilirubin Week 4 N=10	7.97 mg/dL Standard Deviation 6.5
Level of Bilirubin Week 8 N=11	4.72 mg/dL Standard Deviation 4.81

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Omegaven n=15 participants at risk 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.
Cardiac disorders death	6.7% 1/15

Adverse event data not reported

NSLIJ Health System

Phone: 516-472-3650