Trial Outcomes & Findings for Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury (NCT NCT01845116)

NCT ID: NCT01845116

Last Updated: 2022-11-23

Results Overview

Normalization of direct bilirubin is defined as less than 0.4mg/dL by 9 months. This relates to the efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: Month 9
• Results posted on: 2022-11-23

Participant Flow

Participant milestones

Measure	Single Arm Single Omegaven® Intervention Arm Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Baseline characteristics by cohort

Measure	Single Arm n=11 Participants Single Omegaven® Intervention Arm Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Age, Categorical <=18 years	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 9

Normalization of direct bilirubin is defined as less than 0.4mg/dL by 9 months.

This relates to the efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease.

Outcome measures

Measure	Single Arm n=11 Participants Single Omegaven® Intervention Arm Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Number of Participants With Normalization of Direct Bilirubin	11 participants

SECONDARY outcome

Timeframe: Months 1 through 9

EFA is defined at a triene tetraene ratio of greater than 0.2 (so normal is > 0.2). Collected monthly from month 1-9.

Outcome measures

Measure	Single Arm n=11 Participants Single Omegaven® Intervention Arm Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Number of Participants With Normal Essential Fatty Acid (EFA) Profiles.	10 Participants

SECONDARY outcome

Timeframe: baseline data and then weekly and monthly evaluations, for an average of 9 months

Number of participants with triglyceride levels > 400 mg/dL

Outcome measures

Measure	Single Arm n=11 Participants Single Omegaven® Intervention Arm Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Number of Participants With Triglyceride Levels > 400 mg/dL	0 Participants

SECONDARY outcome

Timeframe: Month 6

Outcome measures

Measure	Single Arm n=11 Participants Single Omegaven® Intervention Arm Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Number of Participants With Unexpected Bleeding or Coagulopathies	0 Participants

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Arm n=11 participants at risk Single Omegaven® Intervention Arm Omegaven®: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Metabolism and nutrition disorders Essential fatty acid deficiency	9.1% 1/11 • Number of events 1 • 9 months

Additional Information

Ricardo A. Caicedo, MD

Atrium Health Levine Children's Hospital

Phone: 704-381-8840

Email: ricardo.caicedo@atriumhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place