Compassionate Use of Omegaven IV Fat Emulsion

• Status: Withdrawn
• Trial end date: 2019-02-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sivan Kinberg

Criteria

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.