Non-Alcoholic Fatty Liver DiseaseNCT03801577
Hepaxa Management of Non-alcoholic Fatty Liver Disease
A study testing Hepaxa in people with Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by BASF AS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Hepaxa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
GI Associates and Endoscopy Center
Flowood, Mississippi, 39232
Nick Childers
About this study
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
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Being tested
- Hepaxa
- Keywords
- omega-3, nafld, nafl, nash, medical food
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaxaDietary supplement
High concentrate EPA and DHA
| Study group | Role | What they receive |
|---|---|---|
| Hepaxa | Experimental | Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period) Receives: Dietary Supplement: Hepaxa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study
Blood test
Measured: 6 months
Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study
Blood test
Measured: 6 months
Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study
Blood test
Measured: 6 months
Change in Level of plasma triglycerides from baseline to end of study
Blood test
Measured: 6 months
Change in weight from baseline to end of study
Blood test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BASF AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reed Hogan, MD, Principal investigator, GI Associates and Endoscopy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801577
- Sponsor's protocol ID
- CTN01019401
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03801577
- Acronym / sponsor ID
- CTN01019401
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Keywords
- omega-3, nafld, nafl, nash, medical food
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BASF ASIndustry (pharma, biotech, devices)
- Study start
- Feb 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hepaxa | Experimental | Dietary Supplement: HepaxaSubjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepaxaHigh concentrate EPA and DHA | Dietary supplement | Hepaxa |
Primary outcome
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
5 secondary outcomes
Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study
Time frame: 6 months
Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study
Time frame: 6 months
Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study
Time frame: 6 months
Change in Level of plasma triglycerides from baseline to end of study
Time frame: 6 months
Change in weight from baseline to end of study
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reed Hogan, MD principal investigator
GI Associates and Endoscopy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepaxa in people with Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by BASF AS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in liver fat content (hepatic steatosis) from baseline to end of study (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.