Hepaxa Management of Non-alcoholic Fatty Liver Disease

Not Applicable

• Conditions: Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis
• Interventions: Dietary Supplement: Hepaxa

• Registration Number: NCT03801577
• Lead Sponsor: BASF AS

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Study First Posted: 2019-01-11
• Last Update Posted: 2019-01-11
• Study Start: 2019-02
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Men or women, ≥18 years of age.
2. Suspicion of NAFLD
3. Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
4. CAP score at -6 months and at inclusion of >268
5. A fibroscan elastography score <9 Kpa (Advanced Fibrosis)

Exclusion Criteria

1. Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic.
2. Significant weight loss (> 5% body weight) or rapid weight loss (>1.6 kg/week), within six months of screening.
3. Individuals taking prescription or supplemental omega-3 fatty acids.
4. Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepaxa	Hepaxa	Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)

Primary Outcome Measures

Name	Time	Method
The change in liver fat content (hepatic steatosis) from baseline to end of study	6 months	Liver fat will be measured using the "Controlled Attenuation Parameter" from the ultrasound based Fibroscan machine

Secondary Outcome Measures

Name	Time	Method
Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study	6 months	Blood test
Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study	6 months	Blood test
Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study	6 months	Blood test
Change in Level of plasma triglycerides from baseline to end of study	6 months	Blood test
Change in weight from baseline to end of study	6 months	Blood test

Trial Locations

Locations (1)

GI Associates and Endoscopy Center; 🇺🇸 Flowood, Mississippi, United States