Other Clinical Trial - The HOME Study (HPN With OMEGA-3)

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
	Status	Clinical Trial	Phase
	Active, not recruiting	`NCT04035551` - Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry
	Completed	`NCT01760408` - Sustain, A.S.P.E.N. HPN Registry 2011	N/A

NCT number	NCT03282955
Study type	Interventional
Source	B. Braun Melsungen AG
Contact
Status	Completed
Phase	Phase 4
Start date	January 8, 2018
Completion date	July 19, 2022

The HOME Study (HPN With OMEGA-3) — HOME

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms