An interventional study of Hepaxa in Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver and NASH - Nonalcoholic Steatohepatitis, sponsored by BASF AS. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-11.
Sponsored by BASF AS · Not applicable, Interventional, and Treatment
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.
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.
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →This is the only study on the registry with BASF AS as lead sponsor.
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Exclusion Criteria:
Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)
Dietary Supplement: Hepaxa
High concentrate EPA and DHA
The change in liver fat content (hepatic steatosis) from baseline to end of study
Liver fat will be measured using the "Controlled Attenuation Parameter" from the ultrasound based Fibroscan machine
Time frame: 6 months
Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study
Blood test
Time frame: 6 months
Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study
Blood test
Time frame: 6 months
Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study
Blood test
Time frame: 6 months
Change in Level of plasma triglycerides from baseline to end of study
Blood test
Time frame: 6 months
Change in weight from baseline to end of study
Blood test
Time frame: 6 months
Exploratory outcome. Stratification of effect Hepaxa using FLI score
The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa
Time frame: 6 months
Plan to share: No — Only anonymized data will be shared With the Sponsor. The study protocol and report may be shared, and presented as Scientific posters and peer-reviewed articles.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →