Hepaxa Management of Non-alcoholic Fatty Liver Disease

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

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.

Study Overview

• Status: Unknown
• Conditions: NASH - Nonalcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver
• Intervention / Treatment: Dietary supplement: Hepaxa

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • GI Associates and Endoscopy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hepaxa; Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)	Dietary supplement: Hepaxa; High concentrate EPA and DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: BASF AS
• Investigators: Principal Investigator: Reed Hogan, MD, GI Associates and Endoscopy Center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: omega-3; nafld; nafl; nash; medical food
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CTN01019401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No