Trial Outcomes & Findings for Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease (NCT NCT04697888)

NCT ID: NCT04697888

Last Updated: 2021-06-11

Results Overview

To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 2 participants
• Primary outcome timeframe: Up to 1 year
• Results posted on: 2021-06-11

Participant Flow

Participant milestones

Measure	Overall Study Use of Omegaven for patients with parenteral nutrition associated liver disease. Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=2 Participants Use of Omegaven for patients with parenteral nutrition associated liver disease. Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.
Age, Continuous	4.42 Years STANDARD_DEVIATION 3.58 • n=2 Participants
Sex: Female, Male Female	0 Participants n=2 Participants
Sex: Female, Male Male	2 Participants n=2 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: No results recorded, study was utilized to provide compassionate use of study medication to participants.

To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes.

Outcome measures

Outcome data not reported

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joel Lim, MD - Principal Investigator

Children's Mercy Hospital

Phone: (816)234-3000

Email: jlim@cmh.edu

Results disclosure agreements

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