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Hepaxa Management of Non-alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT03801577
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
BASF AS

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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


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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801577


Locations
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United States, Mississippi
GI Associates and Endoscopy Center Not yet recruiting
Flowood, Mississippi, United States, 39232
Contact: Nick Childers         
Sponsors and Collaborators
BASF AS
Investigators
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Principal Investigator: Reed Hogan, MD GI Associates and Endoscopy Center

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Responsible Party: BASF AS
ClinicalTrials.gov Identifier: NCT03801577     History of Changes
Other Study ID Numbers: CTN01019401
First Posted: January 11, 2019    Key Record Dates
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.

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