Nonalcoholic Fatty Liver DiseasePhase 2NCT04772352

Effects of Febuxostat for Lowering Uric Acid in NAFLD Patients With Gout

A Phase 2 study testing febuxostat treatment and lifestyle intervention in people with Nonalcoholic Fatty Liver Disease, run by Ningbo No. 1 Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Nonalcoholic fatty liver disease (NAFLD) is the most common and harmful chronic liver disease. NAFLD accounts for 49.3% of the total number of chronic liver disease patients in China. It is important to effectively prevent and control NAFLD and its related diseases. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Nonalcoholic Fatty Liver Disease
What is being tested?: febuxostat treatment and lifestyle intervention
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteChina
Study dates: 1 Mar 2021to 1 Mar 2022
Phase: Phase 2
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

with informed consent;
Ages 18-65;
Overweight/obesity: BMI ≥24kg/m2;
A history of gout with serum uric acid levels of > 420μmol/L in men and postmenopausal women, and >360 μmol/L in premenopausal women;
Moderate or above fatty liver was found in the initial screening by ultrasound, and the liver fat content was more than 15% as determined by MRI-PDFF.

Who cannot join

with a history of allergy to febuxostat and allopurinol;
in the acute active phase of gout;
Drinking equivalent to alcohol intake ≥30g/d(male), ≥20g/d(female);
Patients with obvious abnormal liver function: serum transaminase (ALT, AST, GGT one of them) or serum bilirubin (direct bilirubin, indirect bilirubin one of them) exceed 2 times the upper limit of normal reference value; Serum albumin <35g/L;
Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases;
Complicated with renal insufficiency (SCr >133μmol/L) or urinary protein +;

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Complicated coronary heart disease;
Cardiac dysfunction (cardiac function grade 2 or above);
Complementation with diabetes, or fasting blood glucose >7.8mmol/L, or HbA1c >7.5%;
Severe hypertension, blood pressure ≥ 160/100 mmHg;
Patients with asthma and other respiratory diseases;
Intestinal diseases such as inflammatory bowel disease;
Any history of systemic malignancy in the past 5 years;
Morbid obesity (BMI>37.5kg/m2);
Triglyceride ≥5.0 mmol/L was found to be significantly abnormal in baseline examination;
had received systemic hormone or immunosuppressive therapy within 3 months prior to screening, or expected to receive hormone or immunosuppressive therapy in the future;
Use of uric-lowering drugs in the 4 weeks before screening: febuxostat, benzobromarone, allopurinol;
Use of other drugs affecting uric acid metabolism were adjusted within 4 weeks before screening: losartan, fenofibrate, irbesartan, thiazide diuretics, loop medullaral diuretics, compound antihypertensive agents containing diuretics;
Other drugs that may affect liver fat content were taken within 4 weeks before screening;
Weight change ≥5% within 3 months before screening;
Women who are lactating or pregnant or who plan to become pregnant within one year;
were enrolled in other studies within 6 months before screening;
unsuitable for participants to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Ningbo first hospital
Ningbo, Zhejiang, 315000

Other trials in China

About this study

Official title: Effects of Febuxostat for Interventions of Lowering Uric Acid in Patients With Gout With Nonalcoholic Fatty Liver Disease: a Multicenter, Open-label, Randomized, Controlled Study

Previous studies show the level of serum uric acid is significantly elevated in patients with NAFLD. Xanthine oxidase is a key enzyme in uric acid metabolism. It is a new therapeutic target for NAFLD.

This study is aimed to further confirm that hyperuricemia is a new risk factor for NAFLD through a large sample prospective study. Furthermore, this study explore whether Xanthine oxidase (XO), a key enzyme in uric acid metabolism, plays an important role in regulating NAFLD.

Read the detailed description

Previous studies show the level of serum uric acid is significantly elevated in patients with NAFLD. In a large cross-sectional study, the researcher were the first to confirm that serum uric acid level was significantly increased in patients with NAFLD. The results were published in J Hepatol. Xanthine oxidase is a key enzyme in uric acid metabolism. It is a new therapeutic target for NAFLD.

Conditions: Nonalcoholic Fatty Liver Disease
Being tested: febuxostat treatment, lifestyle intervention
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.

febuxostat treatmentDrug
According to NAFLD guidelines, participants accept febuxostat treatment (40mg, once a day, orally)
lifestyle interventionBehavioural
According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).

Study groups in NCT04772352
Study group	Role	What they receive
Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)	Experimental	participants accept febuxostat treatment in addition to lifestyle intervention for 0-48 week. Receives: Drug: febuxostat treatment; Behavioral: lifestyle intervention
Control group: Lifestyle intervention	Active comparator	participants receive lifestyle intervention for 0-24 week. If the results of the 0-24 week study showed that the liver fat content of subjects in the experimental group was significantly lower than that in the control group, control group will accept febuxostat treatment in addition to lifestyle intervention in the next 25-48 week. Receives: Behavioral: lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Liver fat content of subjects in different groups
Liver fat was assessed based on Magnetic Resonance Imaging (MRI).
Measured: at the first week.
Liver fat content of subjects in different groups
Liver fat was assessed based on Magnetic Resonance Imaging (MRI).
Measured: at the 24th week .
Liver fat content of subjects in different groups
Liver fat was assessed based on Magnetic Resonance Imaging (MRI).
Measured: at the 48th week.
Serum uric acid levels of subjects in different groups
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Measured: at the first week
Serum uric acid levels of subjects in different groups
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Measured: at the forth week.
Serum uric acid levels of subjects in different groups
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Measured: at the twelfth week.
Serum uric acid levels of subjects in different groups
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Measured: at the 24th week.
Serum uric acid levels of subjects in different groups
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Measured: at the 36th week.
Serum uric acid levels of subjects in different groups
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Measured: at the 48th week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20211 Mar 2022

First posted26 Feb 2021
Study start1 Mar 2021 (estimated)
Primary completion1 Aug 2021 (estimated)
Study completion1 Mar 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nonalcoholic 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A total of 200 subjects are enrolled in this study. After the initial screening, the subjects were randomly divided into the control group and the drug treatment group. The control group was given lifestyle intervention at 0-24 weeks, and the experimental group was given febuxostat oral therapy on the basis of lifestyle intervention. If the results showed that the reduction of liver fat content of subjects in the lifestyle intervention combined with febuxostat treatment group was significantly better than that in the lifestyle intervention group alone, the original intervention was continued in the drug treatment group, and the control group was given febuxostat orally on the basis of the lifestyle intervention at 24-48 weeks.
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04772352
Sponsor's protocol ID: SUANAFLD V1.0
Status last verified: Feb 2021
First submitted: 23 Feb 2021
Last updated: 26 Feb 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nonalcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Febuxostat for Interventions of Lowering Uric Acid in Patients With Gout With Nonalcoholic Fatty Liver Disease: a Multicenter, Open-label, Randomized, Controlled Study
ClinicalTrials.gov ID: NCT04772352
Acronym / sponsor ID: SUANAFLD V1.0
Conditions: Nonalcoholic Fatty Liver Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: Ningbo No. 1 HospitalUniversity, hospital or other
Study start: 1 Mar 2021 (estimated)
Primary completion: 1 Aug 2021 (estimated)
Study completion: 1 Mar 2022 (estimated)
First posted: 26 Feb 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A total of 200 subjects are enrolled in this study. After the initial screening, the subjects were randomly divided into the control group and the drug treatment group. The control group was given lifestyle intervention at 0-24 weeks, and the experimental group was given febuxostat oral therapy on the basis of lifestyle intervention. If the results showed that the reduction of liver fat content of subjects in the lifestyle intervention combined with febuxostat treatment group was significantly better than that in the lifestyle intervention group alone, the original intervention was continued in the drug treatment group, and the control group was given febuxostat orally on the basis of the lifestyle intervention at 24-48 weeks.

Arm	Type	Receives
Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)	Experimental	Drug: febuxostat treatment, Behavioral: lifestyle interventionparticipants accept febuxostat treatment in addition to lifestyle intervention for 0-48 week.
Control group: Lifestyle intervention	Active comparator	Behavioral: lifestyle interventionparticipants receive lifestyle intervention for 0-24 week. If the results of the 0-24 week study showed that the liver fat content of subjects in the experimental group was significantly lower than that in the control group, control group will accept febuxostat treatment in addition to lifestyle intervention in the next 25-48 week.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

with informed consent;
Ages 18-65;
Overweight/obesity: BMI ≥24kg/m2;
A history of gout with serum uric acid levels of > 420μmol/L in men and postmenopausal women, and >360 μmol/L in premenopausal women;
Moderate or above fatty liver was found in the initial screening by ultrasound, and the liver fat content was more than 15% as determined by MRI-PDFF.

Key exclusion criteria (23 listed)

with a history of allergy to febuxostat and allopurinol;
in the acute active phase of gout;
Drinking equivalent to alcohol intake ≥30g/d(male), ≥20g/d(female);
Patients with obvious abnormal liver function: serum transaminase (ALT, AST, GGT one of them) or serum bilirubin (direct bilirubin, indirect bilirubin one of them) exceed 2 times the upper limit of normal reference value; Serum albumin <35g/L;
Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases;

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
febuxostat treatmentAccording to NAFLD guidelines, participants accept febuxostat treatment (40mg, once a day, orally)	Drug	Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)
lifestyle interventionAccording to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).	Behavioural	Control group: Lifestyle intervention, Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)

Primary outcome

Liver fat content of subjects in different groups
Time frame: at the first week.
Liver fat was assessed based on Magnetic Resonance Imaging (MRI).
Liver fat content of subjects in different groups
Time frame: at the 24th week .
Liver fat was assessed based on Magnetic Resonance Imaging (MRI).
Liver fat content of subjects in different groups
Time frame: at the 48th week.
Liver fat was assessed based on Magnetic Resonance Imaging (MRI).
Serum uric acid levels of subjects in different groups
Time frame: at the first week
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Serum uric acid levels of subjects in different groups
Time frame: at the forth week.
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Serum uric acid levels of subjects in different groups
Time frame: at the twelfth week.
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Serum uric acid levels of subjects in different groups
Time frame: at the 24th week.
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Serum uric acid levels of subjects in different groups
Time frame: at the 36th week.
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.
Serum uric acid levels of subjects in different groups
Time frame: at the 48th week.
blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Individual participant dataSharing planned: No

Related trials for Nonalcoholic Fatty Liver Disease

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing febuxostat treatment and lifestyle intervention in people with Nonalcoholic Fatty Liver Disease, run by Ningbo No. 1 Hospital at 1 site in China.

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 23 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 26 Feb 2021. 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 China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Liver fat content of subjects in different groups (time frame: at the first week.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04772352.

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 26 Feb 2021.