Evaluation of OMEGAVEN 10%® (n-3 EFA Lipid Emulsion) in Home Parenteral Nutrition-associated Liver Disease

NCT01284049 | Completed

• 2 other identifiers: P0812312010-022893-15
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to show that substitution of the usual lipid emulsion (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1 g/kg/infusion of another lipid emulsion, OMEGAVEN 10%® very rich in omega-3 (n-3) (n-6:n-3 ratio = 1:7) induces regression of PNALD due to the anti-inflammatory and anti-fibrotic effects of n-3 EFA. Regression of liver disease will be defined by normalization of the five liver function tests (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.

Conditions

Liver Diseases

Keywords

Home Parenteral Nutrition; Intralipid 20%®; OMEGAVEN 10%®; Liver diseases

Outcome Measures

Primary Outcomes (1)

• The five liver function tests (LFT)

  Regression of liver disease will be defined by normalization of the five liver function tests (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.

  18 weeks after inclusion

Study Arms (2)

Intralipid 20%®

ACTIVE COMPARATOR

reference treatment by standard lipid emulsion not enriched in n-3 EFA (Intralipid 20%®)+ vitamin E.

Drug: Intralipid 20%®

OMEGAVEN 10%®

EXPERIMENTAL

Interventional treatment by a lipid emulsion enriched in n-3 EFA (OMEGAVEN 10%®).

Drug: OMEGAVEN 10%®

Interventions

Intralipid 20%® DRUG

Administration of Intralipid 20%® at a dose ranging between 0.5 and 1 g/kg/infusion during 12 weeks.

Also known as: Arm 1

Intralipid 20%®

OMEGAVEN 10%® DRUG

OMEGAVEN 10%® will be used as the sole lipid supplement at a dose of 0.5 to 1.0 g/kg/Infusion with a maximum dose per infusion of 40 grams, in view of formulation constraints during 12 weeks.

Also known as: Arm 2

OMEGAVEN 10%®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years.
• Patients on HPN for chronic benign intestinal failure:
• with a degree of HPN dependence ≥ two cycles of PN per week with at least one ternary infusion (comprising lipids) per week with a maximum lipid intake of 40 grams per ternary infusion
• Receiving HPN for at least 12 weeks in one of the three study centres, which is a sufficient period to allow resolution of any drug-induced or septic cholestasis and cytolysis related to a previous hospitalisation.
• Presence of PNALD, defined by an abnormality of at least two of the five liver function tests performed (conjugated bilirubin, gamma glutamyltransferase, alkaline phosphatase, AST, ALT).
• Written informed consent.
• Covered by French national health insurance.

You may not qualify if:

• Active cancer, regardless of the primary site.
• Uncontrolled cardiopulmonary insufficiency.
• Decompensated cirrhosis.
• Severe renal failure.
• Uncontrolled diabetes or endocrinopathy.
• Hyperlipoproteinaemia and hypertriglyceridaemia (≥ 3 mmol/L).
• Other causes of liver disease (biliary obstruction, alcohol, hepatitis B virus, hepatitis C virus, CMV, hepatotoxic drugs).
• Systemic corticosteroid therapy or biotherapy (anti-TNF).
• Pregnant women or nursing mothers.
• Known allergy to fish or egg proteins.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Dr Francisca JOLY

Clichy, Hauts de Seine, 92110, France

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

DMAC2L protein, human

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Dr Francisca JOLY

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

FR (1)