Compassionate Use of Omegaven IV Fat Emulsion

• ClinicalTrials.gov Identifier: NCT01323907
• Recruitment Status: Withdrawn
• First Posted: March 28, 2011
• Last Update Posted: February 6, 2020
• Sponsor: Sivan Kinberg
• Information provided by (Responsible Party): Sivan Kinberg, Columbia University

Tracking Information

• First Submitted Date: March 16, 2011
• First Posted Date: March 28, 2011
• Last Update Posted Date: February 6, 2020
• Estimated Study Start Date: January 2011
• Actual Primary Completion Date: February 13, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2011)

Reduction of direct serum bilirubin level (mg/dL) [ Time Frame: Up to 6 months from the completion of the study. ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 24, 2011)

Essential fatty acid profile [ Time Frame: Up to 30 days from therapy completion ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Compassionate Use of Omegaven IV Fat Emulsion
• Official Title: Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Other Name: Omega-3 Fatty Acids

Study Arms

Experimental: Omegaven

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

Intervention: Drug: Omegaven IV lipid emulsion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 4, 2020): 0
• Original Estimated Enrollment (submitted: March 24, 2011): 10
• Actual Study Completion Date: February 13, 2019
• Actual Primary Completion Date: February 13, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Months to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01323907
• Other Study ID Numbers: AAAF2546
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sivan Kinberg, Columbia University
• Study Sponsor: Sivan Kinberg
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sivan Kinberg, MD, MS; Columbia University

• PRS Account: Columbia University
• Verification Date: February 2020