Status:
UNKNOWN
Hepaxa Management of Non-alcoholic Fatty Liver Disease
Lead Sponsor:
BASF AS
Conditions:
Non-Alcoholic Fatty Liver Disease
Non Alcoholic Fatty Liver
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03801577
Start Date
February 1 2019
End Date
December 1 2019
Last Update
January 11 2019
Active Locations (1)
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1
GI Associates and Endoscopy Center
Flowood, Mississippi, United States, 39232