The HOME Study (HPN With OMEGA-3) (NCT03282955) | Clinical Trial Compass
CompletedPhase 4
The HOME Study (HPN With OMEGA-3)
France, Italy, Netherlands74 participantsStarted 2018-01-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion:
* 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
Exclusion:
* 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
* General contraindications to parenteral nutrition (if available from medical records) including:
* Unstable circulatory status with vital threat (states of collapse and shock)
* Acute phase of cardiac infarction or stroke
* Unstable metabolic condit…
What they're measuring
1
Change of Liver Function Parameters From Baseline to Visit 2