The HOME Study (HPN With OMEGA-3)

NCT03282955 | Completed Phase 4 Results

• 1 other identifier: HC-G-H-1403
• Study Type: interventional
• Target: 74
• Locations: 5 countries
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change of Liver Function Parameters From Baseline to Visit 2

  Changes will be expressed as the sum of the N(0.1)- transformed differences of bilirubin, ALT and AST (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters.

  8 weeks

Secondary Outcomes (31)

• Bilirubin

  8 weeks

• Alanine Transaminase (ALT)

  8 weeks

• Aspartate Transaminase (AST)

  8 weeks

• AST/ALT Ratio

  8 weeks

• Alkaline Phosphatase (ALP)

  8 weeks

Study Arms (2)

Lipidem

EXPERIMENTAL

i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)

Drug: Lipidem

Lipofundin MCT

ACTIVE COMPARATOR

i.v. lipid emulsion

Drug: Lipofundin MCT 20%

Interventions

Lipidem DRUG

Lipoplus i.v. lipid emulsion for parenteral nutrition

Lipidem

Lipofundin MCT 20% DRUG

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

Lipofundin MCT

Eligibility Criteria

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

You may qualify if:

• Signed informed consent available
• Male or female patients ≥ 18 years of age
• Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 3 months
• Patients receiving ≥ 3.0 g lipids/kg body weight per week

You may not qualify if:

• Persistent high total bilirubin values in medical history of last 6 months (\> 40µmol/l)
• Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
• Patients with history of cancer and anti-cancer treatment within the last 2 years
• Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients
• Patients treated in the past or currently with Teduglutide
• Contraindications to investigational products (if available from medical records) including:
• Severe hyperlipidemia, including severe hypertriglyceridaemia (≥1000 mg/dl or 11.4 mmol/l)
• Severe coagulopathy
• Intrahepatic cholestasis
• Severe hepatic insufficiency
• Severe renal insufficiency in absence of renal replacement therapy
• Acute thromboembolic events
• Fat embolism
• Aggravating haemorrhagic diatheses
• Metabolic acidosis

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (9)

Hôpital Archet 2 - Unité de support nutritionnel

Nice, France

Location

Hospices Civiles de Lyon - Centre hospitalier Lyon Sud

Pierre-Bénite, France

Location

Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital

Bologna, Italy

Location

Radboud university medical center

Nijmegen, Netherlands

Location

Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej

Lodz, Poland

Location

Stanley Dudrick's Memorial Hospital

Skawina, Poland

Location

Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii

Warsaw, Poland

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

University College Hospital London

London, United Kingdom

Location

Related Publications (2)

• Klek S, Chambrier C, Szczepanek K, Kunecki M, Sobocki J, Wanten G, Pironi L, Schneider SM, Rahman F, Cooper SC, Calder PC, Gabe S, Forbes A. Safe and well-tolerated long-term parenteral nutrition regimen: Omega-3-fatty-acid-enriched medium chained/ long chained triglycerides emulsion. Clin Nutr. 2024 Dec;43(12):415-424. doi: 10.1016/j.clnu.2024.11.007. Epub 2024 Nov 7.

  PMID: 39581180 DERIVED

• Klek S, Chambrier C, Cooper SC, Gabe S, Kunecki M, Pironi L, Rahman F, Sobocki J, Szczepanek K, Wanten G, Lincke N, Glotzbach B, Forbes A. Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial. Trials. 2019 Dec 30;20(1):808. doi: 10.1186/s13063-019-3994-z.

  PMID: 31888740 DERIVED

Results Point of Contact

• Title: Study Manager
• Organization: B. Braun Melsungen

studies@bbraun.com

05661/71

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: September 14, 2017
• Study Start: January 8, 2018
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-06

Locations

FR (2); NL (1); PL (3); IT (1); GB (2)