Compassionate Use of Omegaven IV Fat Emulsion

NCT ID: NCT01323907

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2019-02-13

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.

Conditions

Total Parenteral Nutrition-induced Cholestasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omegaven

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

Group Type: EXPERIMENTAL

Omegaven IV lipid emulsion

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Omega-3 Fatty Acids

Eligibility 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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sivan Kinberg

OTHER

Sponsor Role: lead

Responsible Party

Sivan Kinberg

Assistant Professor of Pediatrics at the Columbia University Medical Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sivan Kinberg, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia Presbyterian Medical Center-Children's Hospital of NY

New York, New York, United States

Countries

United States

Other Identifiers

AAAF2546

Identifier Type: -

Identifier Source: org_study_id