Hepaxa Management of Non-alcoholic Fatty Liver Disease | NCT03801577

Studies
Hepaxa Management of Non-alcoholic Fatty Liver Disease

NCT03801577

Sponsor

BASF AS

Status

Unknown status

Last Update Posted

Jan 11, 2019Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Non-Alcoholic Fatty Liver Disease
Non Alcoholic Fatty Liver
NASH - Nonalcoholic Steatohepatitis

Interventions

Hepaxa

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2019Estimated

Primary Completion Date

Oct 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jan 9, 2019

First Submission Date that Met QC Criteria

Jan 10, 2019

First Posted Date

Jan 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2019

Last Update Posted Date

Jan 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepaxa	Experimental	Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)	Dietary Supplement: Hepaxa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepaxa	Dietary Supplement	High concentrate EPA and DHA	Hepaxa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study	Blood test	6 months
Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study

Other Outcomes

Measure	Description	Time Frame
Exploratory outcome. Stratification of effect Hepaxa using FLI score	The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa	6 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reed Hogan, MD	GI Associates and Endoscopy Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GI Associates and Endoscopy Center		Flowood	Mississippi	39232	United States

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

Not provided