Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03801577
Status:
UNKNOWN
Last Update Posted:
2019-01-11
First Post:
2019-01-09
Brief Title:
Hepaxa Management of Non-alcoholic Fatty Liver Disease
Sponsor:
BASF AS
Organization:
BASF AS
Study Overview
Official Title:
Hepaxa Management of Non-Alcoholic Fatty Liver Disease NAFLD A Real-world Pilot Study Observing Effects of Nutritional Management With Hepaxa in Subjects With Liver Steatosis
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to real-world use
Detailed Description:
Subjects With fatty liver are given Hepaxa for 6 months Fibroscan CAP measurements are taken at 3 monthly intervals Subjects consent to Collection of data from approximately 6 months prior to use of Hepaxa Patients unresponsive to life style recommendations given as standard practice will be enrolled
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