Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

• Sponsor: Arthur J De Lorimier (Other)
• Overall Status: Completed
• CT.gov ID: NCT01601652
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 85
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Condition or Disease	Intervention/Treatment	Phase
Parenteral Nutrition Associated Cholestasis	Drug: Omegaven	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omeagven	Drug: Omegaven; 1 g/kg/d iv infusion over 24h

Outcome Measures

Primary Outcome Measures

1. Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) [approximately for 4 months]

Secondary Outcome Measures

1. Liver Transaminases [approximately for 4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Cholestasis defined as either

• serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR

• serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis

Exclusion Criteria:

• Age > 1y at time that omegaven is started

• Not expected to survive at least 30 days

• Fish allergy in a first degree relative

• Hemodynamic instability

• Coagulopathy

• Not likely to require PN for > 30d

• Not expected to survive > 30d

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis Medical Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• Arthur J De Lorimier

Investigators

• Principal Investigator: Ian J Griffin, MD, UC Davis

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 12, 2018
• Informed Consent Form - Feb 12, 2018

More Information

Publications

None provided.

• Responsible Party: Arthur J De Lorimier, Associate Professor of Pediatrics, University of California, Davis
• ClinicalTrials.gov Identifier: NCT01601652
• Other Study ID Numbers: 225576; UCD#225576-3
• First Posted: May 18, 2012
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Arthur J De Lorimier, Associate Professor of Pediatrics, University of California, Davis: cholestasis; PNAC; Parenteral Nutrition Associated Cholestasis; PNALD; Parenteral Nutrition Associated Liver Disease
• Additional relevant MeSH terms: Cholestasis

Study Results

Participant Flow

Recruitment Details	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])

Arm/Group Title	Omeagven
Arm/Group Description	Omegaven: 1 g/kg/d iv infusion over 24h
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Omeagven
Arm/Group Description	Omegaven: 1 g/kg/d iv infusion over 24h
Overall Participants	12
Age (month) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [month]	10 (1)
Sex: Female, Male (Count of Participants)
Female	3 25%
Male	9 75%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
Time Frame	approximately for 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omeagven
Arm/Group Description	Omegaven: 1 g/kg/d iv infusion over 24h
Measure Participants	11
Mean (Standard Deviation) [mg/dl]	2 (0.2)

2. Secondary Outcome

Title	Liver Transaminases
Time Frame	approximately for 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omeagven
Arm/Group Description	Omegaven: 1 g/kg/d iv infusion over 24h
Measure Participants	11
Mean (Standard Deviation) [mg/dl]	98 (10)

Adverse Events

Time Frame	36 mo
Arm/Group Title	Omeagven
Arm/Group Description	Omegaven: 1 g/kg/d iv infusion over 24h
All Cause Mortality
	Omeagven
	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)
Serious Adverse Events
	Omeagven
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Omeagven
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Gastrointestinal disorders
hypertriglyceridemia	0/12 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.