Trial Outcomes & Findings for A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease (NCT NCT00969332)
NCT ID: NCT00969332
Last Updated: 2020-02-26
Results Overview
weeks
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)
Results posted on
2020-02-26
Participant Flow
Recruitment for this study began in May 2005. Patients were recruited from the inpatient and outpatient setting at the University of California, Los Angeles.
There was no wash-out or run-in period.
Participant milestones
| Measure |
Omegaven
Omegaven, 0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Omegaven
Omegaven, 0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
|
|---|---|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Baseline characteristics by cohort
| Measure |
Omegaven
n=59 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Age, Categorical
<=18 years
|
58 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
707.9 days
STANDARD_DEVIATION 1366.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)weeks
Outcome measures
| Measure |
Omegaven
n=59 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Time to Reversal of Parenteral Nutrition Associated Cholestasis
|
12.1 weeks
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 24 weeks, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)expiration
Outcome measures
| Measure |
Omegaven
n=59 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Death
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)includes isolated liver or multi-visceral transplant including liver graft
Outcome measures
| Measure |
Omegaven
n=59 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Number of Participants Who Underwent a Transplant
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)discontinuation of parenteral nutrition
Outcome measures
| Measure |
Omegaven
n=59 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Time to Full Enteral Feeds
|
12.49 weeks
Standard Deviation 5.59
|
SECONDARY outcome
Timeframe: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)Weight Z-scores at the end of the study. Formula used: (weight at end of study-average weight of reference population)/standard deviation of weight of reference population. The Z-score indicates the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A weight Z-score \</= -2 indicates an underweight or malnourished status, while a weight Z-score \>/= 2 indicates an overweight or obese status.
Outcome measures
| Measure |
Omegaven
n=59 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Growth Z-scores
|
-0.66 Z-score
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)platelet counts at the end of the study
Outcome measures
| Measure |
Omegaven
n=59 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Platelet Counts at the End of the Study - Risk of Bleeding
|
220.9 x10^3 cells/mL
Standard Deviation 134.3
|
SECONDARY outcome
Timeframe: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)triene:tetraene ratio less than 0.2
Outcome measures
| Measure |
Omegaven
n=17 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Number of Participants With Essential Fatty Acid Deficiency
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)Serum Cytokines - interleukin-8
Outcome measures
| Measure |
Omegaven
n=14 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Markers of Inflammation
|
16 pg/mL
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)Serum Phytosterols - stigmasterol
Outcome measures
| Measure |
Omegaven
n=14 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Markers of Sterol Metabolism
|
0.1 mg/dL
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)Serum Bile acids - total chenodeoxycholic acid
Outcome measures
| Measure |
Omegaven
n=14 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Markers of Bile Acid Metabolism
|
4 umol/L
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)Erythrocyte fatty acid - Docosahexaenoic Acid
Outcome measures
| Measure |
Omegaven
n=14 Participants
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Markers of Fatty Acid Metabolism
|
12.7 Percent of Sum of Fatty Acids
Standard Deviation 0.7
|
Adverse Events
Omegaven
Serious events: 35 serious events
Other events: 53 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Omegaven
n=59 participants at risk
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Infections and infestations
Sepsis
|
42.4%
25/59 • Number of events 39 • 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.6%
8/59 • Number of events 10 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
15.3%
9/59 • Number of events 12 • 24 weeks
|
|
Cardiac disorders
Hypotension
|
11.9%
7/59 • Number of events 9 • 24 weeks
|
|
Renal and urinary disorders
Increased Creatinine
|
1.7%
1/59 • Number of events 31 • 24 weeks
|
|
Blood and lymphatic system disorders
Bleeding
|
16.9%
10/59 • Number of events 16 • 24 weeks
|
|
Gastrointestinal disorders
Necrotizing Enterocolitis
|
1.7%
1/59 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
5.1%
3/59 • Number of events 4 • 24 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
10.2%
6/59 • Number of events 6 • 24 weeks
|
|
Nervous system disorders
Seizures
|
1.7%
1/59 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Omegaven
n=59 participants at risk
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
|
|---|---|
|
Cardiac disorders
Hypotension
|
5.1%
3/59 • Number of events 3 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
23.7%
14/59 • Number of events 19 • 24 weeks
|
|
General disorders
Hyponatremia
|
18.6%
11/59 • Number of events 37 • 24 weeks
|
|
General disorders
Hypertriglyceridemia
|
5.1%
3/59 • Number of events 7 • 24 weeks
|
|
General disorders
Metabolic Acidosis
|
10.2%
6/59 • Number of events 7 • 24 weeks
|
|
Gastrointestinal disorders
Bowel Rejection
|
1.7%
1/59 • Number of events 1 • 24 weeks
|
|
General disorders
Acute Life Threatening Event
|
1.7%
1/59 • Number of events 1 • 24 weeks
|
|
Renal and urinary disorders
Increased Creatinine
|
3.4%
2/59 • Number of events 10 • 24 weeks
|
|
Endocrine disorders
Hypoglycemia
|
66.1%
39/59 • Number of events 247 • 24 weeks
|
|
Endocrine disorders
Hyperglycemia
|
40.7%
24/59 • Number of events 73 • 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
47.5%
28/59 • Number of events 148 • 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
25.4%
15/59 • Number of events 28 • 24 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
39.0%
23/59 • Number of events 106 • 24 weeks
|
|
Blood and lymphatic system disorders
Increased International Normalized Ratio
|
35.6%
21/59 • Number of events 106 • 24 weeks
|
|
Blood and lymphatic system disorders
Clinical Bleeding
|
15.3%
9/59 • Number of events 17 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place