Compassionate Use of Omegaven IV Fat Emulsion

Total Parenteral Nutrition-induced Cholestasis Clinical Trial

Official title:

Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01323907
• Other study ID #: AAAF2546
• Status: Withdrawn
• Phase: N/A
• Start date: January 2011
• Est. completion date: February 13, 2019

Study information

• Verified date: February 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholestasis
• Total Parenteral Nutrition-induced Cholestasis

Intervention

Drug:
• Omegaven IV lipid emulsion
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.

Locations

Country	Name	City	State
United States	Columbia Presbyterian Medical Center-Children's Hospital of NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sivan Kinberg

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Essential fatty acid profile	Previous studies have found no association between Omegaven administration and essential fatty acid deficiency. Due to theoretical concern for developing fatty acid deficiency with low dose Omegaven administration, these levels will be followed during Omegaven therapy.	Up to 30 days from therapy completion