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Compassionate Use of Omegaven IV Fat Emulsion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01323907
Recruitment Status : Withdrawn (Omegaven is now FDA approved.)
First Posted : March 28, 2011
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Sivan Kinberg, Columbia University

Tracking Information
First Submitted Date  ICMJE March 16, 2011
First Posted Date  ICMJE March 28, 2011
Last Update Posted Date February 6, 2020
Estimated Study Start Date  ICMJE January 2011
Actual Primary Completion Date February 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compassionate Use of Omegaven IV Fat Emulsion
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Total Parenteral Nutrition-induced Cholestasis
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 4, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2011)
10
Actual Study Completion Date  ICMJE February 13, 2019
Actual Primary Completion Date February 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01323907
Other Study ID Numbers  ICMJE AAAF2546
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sivan Kinberg, Columbia University
Study Sponsor  ICMJE Sivan Kinberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sivan Kinberg, MD, MS Columbia University
PRS Account Columbia University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP