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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 25, 2014
Last verified: August 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 ≥ 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

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 25, 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 September 16, 2014