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

This study is currently recruiting participants.
Verified March 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01284049
First received: January 25, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Liver Diseases
Drug: Intralipid 20%®
Drug: OMEGAVEN 10%®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study in Adults on HPN Who Have Developed PNALD Comparing Equivalent Doses of Two Lipid Emulsions: OMEGAVEN 10%®, Enriched in n-3 EFA, and a Standard Lipid Emulsion, Intralipid 20%® Not Enriched in n-3 EFA + Vitamin E Supplement

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The five liver function tests (LFT) [ Time Frame: 18 weeks after inclusion ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 64
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intralipid 20%®
reference treatment by standard lipid emulsion not enriched in n-3 EFA (Intralipid 20%®)+ vitamin E.
Drug: Intralipid 20%®
Administration of Intralipid 20%® at a dose ranging between 0.5 and 1 g/kg/infusion during 12 weeks.
Other Name: Arm 1
Experimental: OMEGAVEN 10%®
Interventional treatment by a lipid emulsion enriched in n-3 EFA (OMEGAVEN 10%®).
Drug: OMEGAVEN 10%®
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.
Other Name: Arm 2

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years.
  • Patients on HPN for chronic benign intestinal failure:

with a degree of HPN dependence ≥ three 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

  • Expected duration of HPN dependence greater than 18 weeks at the time of inclusion.
  • 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).
  • Stable patient with no infection during the six weeks preceding inclusion.
  • Medical examination performed before inclusion.
  • Written informed consent.
  • Covered by French national health insurance.

Exclusion Criteria:

  • 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.
  • Inclusion in another study terminated or less than three months.
  • Known allergy to fish or egg proteins.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284049

Contacts
Contact: Dr Francisca JOLY 01 40 87 56 16
Contact: Pr Bernard MESSING 01 40 87 56 16

Locations
France
Dr Francisca JOLY Recruiting
Clichy, Hauts de Seine, France, 92110
Contact: Dr Francisca JOLY         
Principal Investigator: Dr Francisca JOLY         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Dr Francisca JOLY Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01284049     History of Changes
Other Study ID Numbers: P081231, 2010-022893-15
Study First Received: January 25, 2011
Last Updated: March 12, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Home Parenteral Nutrition
Intralipid 20%®
OMEGAVEN 10%®
Liver diseases

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014