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

Parenteral Nutrition Associated Cholestasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601652
• Other study ID #: 225576
• Secondary ID: UCD#225576-3
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2011
• Est. completion date: December 2018

Study information

• Verified date: January 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Parenteral Nutrition Associated Cholestasis

Intervention

Drug:
• Omegaven
1 g/kg/d iv infusion over 24h

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Arthur J De Lorimier

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)		approximately for 4 months
Secondary	Liver Transaminases		approximately for 4 months