Back to resultsHepaxa Management of Non-alcoholic Fatty Liver Disease
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hepaxa
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring omega-3, nafld, nafl, nash, medical food
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- GI Associates and Endoscopy Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hepaxa
Arm Description
Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study
Blood test
Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study
Blood test
Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study
Blood test
Change in Level of plasma triglycerides from baseline to end of study
Blood test
Change in weight from baseline to end of study
Blood test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03801577
Brief Title
Hepaxa Management of Non-alcoholic Fatty Liver Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BASF AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
Keywords
omega-3, nafld, nafl, nash, medical food
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hepaxa
Arm Type
Experimental
Arm Description
Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)
Intervention Type
Dietary Supplement
Intervention Name(s)
Hepaxa
Intervention Description
High concentrate EPA and DHA
Primary Outcome Measure Information:
Title
The change in liver fat content (hepatic steatosis) from baseline to end of study
Description
Liver fat will be measured using the "Controlled Attenuation Parameter" from the ultrasound based Fibroscan machine
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study
Description
Blood test
Time Frame
6 months
Title
Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study
Description
Blood test
Time Frame
6 months
Title
Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study
Description
Blood test
Time Frame
6 months
Title
Change in Level of plasma triglycerides from baseline to end of study
Description
Blood test
Time Frame
6 months
Title
Change in weight from baseline to end of study
Description
Blood test
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Exploratory outcome. Stratification of effect Hepaxa using FLI score
Description
The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reed Hogan, MD
Organizational Affiliation
GI Associates and Endoscopy Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
GI Associates and Endoscopy Center
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Childers
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Hepaxa Management of Non-alcoholic Fatty Liver Disease
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