Hepaxa Management of Non-alcoholic Fatty Liver Disease

• ClinicalTrials.gov Identifier: NCT03801577
• Recruitment Status: Unknown
• First Posted: January 11, 2019
• Last Update Posted: January 11, 2019
• Sponsor: BASF AS
• Information provided by (Responsible Party): BASF AS

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis	Dietary Supplement: Hepaxa	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Subjects are screened for eligibility and on consent, historical data from liver fat measurements With CAP scores, will be collected from the previous 6 months. Only subjects With no, or poor response to lifestyle recommendations will be enrolled.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: February 2019
• Estimated Primary Completion Date: October 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study [ Time Frame: 6 months ]
   Blood test
2. Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study [ Time Frame: 6 months ]
   Blood test
3. Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study [ Time Frame: 6 months ]
   Blood test
4. Change in Level of plasma triglycerides from baseline to end of study [ Time Frame: 6 months ]
   Blood test
5. Change in weight from baseline to end of study [ Time Frame: 6 months ]
   Blood test

Other Outcome Measures:

1. Exploratory outcome. Stratification of effect Hepaxa using FLI score [ Time Frame: 6 months ]
   The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Mississippi

GI Associates and Endoscopy Center

Flowood, Mississippi, United States, 39232

Contact: Nick Childers

Sponsors and Collaborators

BASF AS

Investigators

• Principal Investigator: Reed Hogan, MD; GI Associates and Endoscopy Center

More Information

• Responsible Party: BASF AS
• ClinicalTrials.gov Identifier: NCT03801577
• Other Study ID Numbers: CTN01019401
• First Posted: January 11, 2019
• Last Update Posted: January 11, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BASF AS:

omega-3; nafld; nafl; nash; medical food

Additional relevant MeSH terms:

Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases