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Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

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: NCT01601652
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2012
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Arthur J De Lorimier, University of California, Davis

Brief Summary:
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Associated Cholestasis Drug: Omegaven Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Study Start Date : November 2011
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: Omeagven Drug: Omegaven
1 g/kg/d iv infusion over 24h




Primary Outcome Measures :
  1. Normalization of conjugated bilirubin (conjugated bilirubin < 2 mg/dL) [ Time Frame: approximately for 4 months ]

Secondary Outcome Measures :
  1. Liver transaminases [ Time Frame: approximately for 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cholestasis defined as either

  • serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
  • serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis

Exclusion Criteria:

  • Age > 1y at time that omegaven is started
  • Not expected to survive at least 30 days
  • Fish allergy in a first degree relative
  • Hemodynamic instability
  • Coagulopathy
  • Not likely to require PN for > 30d
  • Not expected to survive > 30d

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601652


Locations
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United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Arthur J De Lorimier
Investigators
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Principal Investigator: Ian J Griffin, MD UC Davis
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Responsible Party: Arthur J De Lorimier, Associate Professor of Pediatrics, University of California, Davis
ClinicalTrials.gov Identifier: NCT01601652    
Other Study ID Numbers: 225576
UCD#225576-3 ( Other Identifier: UC Davis )
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by Arthur J De Lorimier, University of California, Davis:
cholestasis
PNAC
Parenteral Nutrition Associated Cholestasis
PNALD
Parenteral Nutrition Associated Liver Disease
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases