Hepaxa Management of Non-alcoholic Fatty Liver Disease

Status unconfirmed · Not applicable

Conditions studied: Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT03801577

Run by

BASF AS

People needed

50

Starts

2019-02-01

Expected to finish

2019-12-01

Last updated by the study team

2019-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Significant weight loss (> 5% body weight) or rapid weight loss (>1.6 kg/week), within six months of screening.
• Individuals taking prescription or supplemental omega-3 fatty acids.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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