Trial Outcomes & Findings for Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis (NCT NCT01601652)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

approximately for 4 months

Results posted on

2021-01-27

Participant Flow

Started Omegaven: N=12 1 Died of complications not related to omegavin 5 Weaned off PN before DC (2F, 3M) 6 Discharged Home on PN (of these 3 remain on PN\[all male\]; 3 weaned off after DC \[2M, 1F\])

Participant milestones

Participant milestones
Measure	Omeagven Omegaven: 1 g/kg/d iv infusion over 24h
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Omeagven Omegaven: 1 g/kg/d iv infusion over 24h
Overall Study Death	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omeagven n=12 Participants Omegaven: 1 g/kg/d iv infusion over 24h
Age, Continuous	10 month STANDARD_DEVIATION 1 • n=12 Participants
Sex: Female, Male Female	3 Participants n=12 Participants
Sex: Female, Male Male	9 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants

PRIMARY outcome

Timeframe: approximately for 4 months

Outcome measures

Outcome measures
Measure	Omeagven n=11 Participants Omegaven: 1 g/kg/d iv infusion over 24h
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)	2 mg/dl Standard Deviation 0.2

SECONDARY outcome

Timeframe: approximately for 4 months

Outcome measures

Outcome measures
Measure	Omeagven n=11 Participants Omegaven: 1 g/kg/d iv infusion over 24h
Liver Transaminases	98 mg/dl Standard Deviation 10

Adverse Events

Omeagven

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Omeagven n=12 participants at risk Omegaven: 1 g/kg/d iv infusion over 24h
Gastrointestinal disorders hypertriglyceridemia	0.00% 0/12 • 36 mo

Additional Information

Arthur J de Lorimier, Director of Pediatric Gastroenterology

UC Davis

Phone: 916-734-3112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place