NCT03662282

Omegaven as Alternative Parenteral Fat Nutrition

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Not accepted

Summary

To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis

Detailed description

An intermediate population, Investigational New Drug study, to provide an alternate intravenous fat nutrition, Omegaven®, to help improve liver function while providing adequate nutrition for critically ill infants with parenteral nutrition associated cholestasis

Conditions

• Cholestasis
• Cholestasis of Parenteral Nutrition

Interventions

Type	Name	Description
DRUG	Omegaven	Omegaven® fat emulsion will be used as a compassionate use treatment for critically ill infants with parenteral nutrition associated liver injury

Timeline

• Start date: 2018-10-23
• Primary completion: 2019-01-07
• Completion: 2019-01-07
• First posted: 2018-09-07
• Last updated: 2020-07-22
• Results posted: 2020-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study