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The HOME Study (HPN With OMEGA-3)

NCT03282955 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-07-04

Study results available
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Summary

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

Conditions

  • Patients Requiring Home Parenteral Nutrition

Interventions

DRUG

Lipidem

Lipoplus i.v. lipid emulsion for parenteral nutrition

DRUG

Lipofundin MCT 20%

Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2022-07-19
Completion
2022-07-19

Countries

  • France
  • Italy
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282955 on ClinicalTrials.gov