NCT01601652

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 27, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

7.1 years

First QC Date

May 9, 2012

Results QC Date

November 17, 2020

Last Update Submit

January 25, 2021

Conditions

Parenteral Nutrition Associated Cholestasis

Keywords

cholestasisPNACParenteral Nutrition Associated CholestasisPNALDParenteral Nutrition Associated Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)

    approximately for 4 months

Secondary Outcomes (1)

  • Liver Transaminases

    approximately for 4 months

Study Arms (1)

Omeagven

EXPERIMENTAL
Drug: Omegaven

Interventions

OmegavenDRUG

1 g/kg/d iv infusion over 24h

Omeagven

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Cholestasis

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Results Point of Contact

Title
Arthur J de Lorimier, Director of Pediatric Gastroenterology
Organization
UC Davis
adelorimier@ucdavis.edu
916-734-3112

Study Officials

  • Ian J Griffin, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 18, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 27, 2021

Results First Posted

January 27, 2021

Record last verified: 2021-01

Locations

US(1)