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OpenTrials
Completed

NCT Number: NCT01601652

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

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

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Key information

Conditions

Parenteral Nutrition Associated Cholestasis Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omegaven

Drug

1 g/kg/d iv infusion over 24h

Primary outcomes

  1. Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)

    Time frame: approximately for 4 months

Secondary outcomes

  1. Liver Transaminases

    Time frame: approximately for 4 months

Sponsors and collaborators

Lead sponsor

Arthur J De Lorimier

Other

Registry information

Official study title

Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
May 18, 2012
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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