NCT01194063 is a Phase 3 clinical trial of Omega-3 fish oil lipid emulsion in Cholestasis, sponsored by Kapiolani Medical Center For Women & Children.

Who is sponsoring NCT01194063?

NCT01194063 is sponsored by Kapiolani Medical Center For Women & Children.

What drugs are being tested in NCT01194063?

Interventions in NCT01194063: Omega-3 fish oil lipid emulsion.

What condition does NCT01194063 study?

NCT01194063 studies Cholestasis.

Is NCT01194063 still recruiting?

NCT01194063 is currently completed. Last updated 3 April 2026.

Last reviewed 2026-04-03 · How we verify

NCT01194063

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Completed Phase 3 Last updated 3 April 2026

What this trial tests

Phase 3 trial testing Omega-3 fish oil lipid emulsion in Cholestasis in 36 participants. Completed in 15 January 2019.

Timeline

20 October 2010

Primary endpoint
30 November 2018

15 January 2019

Quick facts

Lead sponsor	Kapiolani Medical Center For Women & Children
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	20 October 2010
Primary completion	30 November 2018
Estimated completion	15 January 2019
Sites	1 location across United States

Drugs / interventions tested

Omega-3 fish oil lipid emulsion — full drug profile →

Conditions studied

Cholestasis — all drugs for Cholestasis →

Sponsor

Kapiolani Medical Center For Women & Children

Who can join

Under 18, any sex, with Cholestasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Use of Fish Oil-Based Lipid Emulsions in Infants With Intestinal Failure-Associated Liver Disease: A Case Series.
St-Jules DE, Watters CA, Iwamoto LM. · · 2014 · cited 11× · PMID 24527173 · DOI 10.1177/1941406413513461

Verify or expand the search:

Other recruiting trials for Cholestasis

Currently open trials in the same condition.

NCT04167358 — Linerixibat Long-term Safety, and Tolerability Study · Phase 3 · active not recruiting
NCT05582447 — Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01194063 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kapiolani Medical Center For Women & Children
Last refreshed: 3 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01194063.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing