Hepaxa Management of Non-alcoholic Fatty Liver Disease

BASF

Status: Unknown

Conditions: Non Alcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Hepaxa

Study type: Interventional

Funder types: Industry

Identifiers

NCT03801577

CTN01019401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Hepaxa

Experimental group

Description:

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

Treatment:

Dietary Supplement: Hepaxa