Ignite Creation Date:
2024-05-06 @ 10:32 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03282955
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2017-08-10
Brief Title:
The HOME Study HPN With OMEGA-3
Sponsor:
B Braun Melsungen AG
Organization:
B Braun Melsungen AG
Study Overview
Official Title:
A Randomized Controlled Double-blind Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCTLCT Lipid Emulsion
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOME
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None