NCT01323907

Brief Summary

The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

8.1 years

First QC Date

March 16, 2011

Last Update Submit

February 4, 2020

Conditions

Total Parenteral Nutrition-induced Cholestasis

Keywords

Total Parenteral Nutrition-induced CholestasisOmegavenliver diseaseCholestasisFat emulsions

Outcome Measures

Primary Outcomes (1)

  • Reduction of direct serum bilirubin level (mg/dL)

    For effectiveness endpoint, the allowable minimum time interval between serial direct bilirubin measurements that will determine reversal of cholestasis is 2 consecutive measurements of direct bilirubin \< or = to 2mg/dL obtained at least 2 weeks apart.

    Up to 6 months from the completion of the study.

Secondary Outcomes (1)

  • Essential fatty acid profile

    Up to 30 days from therapy completion

Study Arms (1)

Omegaven

EXPERIMENTAL

Omegaven IV lipid emulsion administration for infants with life threatening parenteral nutrition associated liver disease

Drug: Omegaven IV lipid emulsion

Interventions

Omegaven IV lipid emulsionDRUG

For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition.

Also known as: Omega-3 Fatty Acids
Omegaven

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of life threatening PNALD
  • Dependent on Parenteral Nutrition for caloric needs
  • Expected to require PN for at least another 30 days
  • Other causes of liver disease have been excluded
  • GI/Liver service is involved in patient care
  • Standard therapies for the treatment of PNALD must have been utilized prior to initiating omegaven.
  • Inpatient at Morgan Stanley Children's Hospital of NewYork Presbyterian Hospital
  • Must be at least 2 months of age

You may not qualify if:

  • Not inpatient
  • Younger than 2 months of age
  • Expected to be weaned off of parenteral nutrition within 30 days
  • have other documented causes of liver disease
  • have signs of proven severe advanced liver disease
  • Allergy to seafood, egg protein and/or previous allergy to Omegaven
  • active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI, cholestasis due to any reason other than PNALD, active new infection at time of initiation of Omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring
  • must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians).
  • Parent or legal guardian must be willing to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Presbyterian Medical Center-Children's Hospital of NY

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Liver DiseasesCholestasis

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Digestive System DiseasesBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Sivan Kinberg, MD, MS

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Pediatrics at the Columbia University Medical Center

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 28, 2011

Study Start

January 1, 2011

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

US(1)