Compassionate Use of Omegaven IV Fat Emulsion

Sivan Kinberg

Status

Withdrawn

Conditions

Total Parenteral Nutrition-induced Cholestasis

Treatments

Drug: Omegaven IV lipid emulsion

Study type

Interventional

Funder types

Other

Identifiers

NCT01323907

AAAF2546

Details and patient eligibility

About

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.

Sex

All

Ages

2 months to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.