NASH - Nonalcoholic SteatohepatitisENDONASHNCT04653311
Evaluation of an Endoscopic Sutured Gastroplasty in Patients With NonAlcoholic Steatohepatitis (NASH) and Fibrosis.
A study testing Endomina® in people with NASH - Nonalcoholic Steatohepatitis, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver diseases characterized by liver steatosis which can, in a minority of patients, progress to nonalcoholic steatohepatitis (NASH), fibrosis, and ultimately hepatocellular carcinoma and liver failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Endomina®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jun 2020to 23 Dec 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 27 to 40 kg/m².
- Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to Screening or during the Screening Period) with at least 1 in each component of the NAS (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
- NAS ≥4.
- Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
- Patients in whom it is safe and practical to proceed with a liver biopsy (in accordance with the current guidelines), and who agree to have:
- 1 liver biopsy during the Screening Period for diagnostic purpose (if no historical biopsy within 6 months before screening is available)
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- a final liver biopsy after 1 year of treatment for assessment of the treatment effects on NASH and fibrosis
- For patients with type 2 diabetes, glycemia must be controlled (HbA1c < 9.0%). If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:
- No qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for patients treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists or insulin. Dose changes of these medications are allowed in the 6 months prior to diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable dose in the 6 months prior to diagnostic liver biopsy.
- No implementation of GLP-1 agonists and SGLT2 inhibitors up to 1 year.
- Initiation of any other antidiabetic drugs is allowed after randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations.
- Must be able to understand and be willing to provide written informed consent.
- Must live within 75 km of the treatment site.
- In case of obesity, had followed the bariatric multidisciplinary workup (blood analyses, dietician,psychologist and doctor appointments).
Who cannot join
- Other well documented causes of chronic liver disease according to standard diagnostic procedures including, but not restricted to:
- Positive hepatitis B surface antigen (HBsAg)
- Positive HCV RNA, (tested for in case of known cured HCV infection, or positive HCV Ab at Screening)
- Suspicion of drug-induced liver disease
- Alcoholic liver disease
- Autoimmune hepatitis
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- Wilson's disease
- Primary biliary cholangiopathy, primary sclerosing cholangitis
- Genetic homozygous hemochromatosis
- Presence of HCC
- History or planned liver transplant, or current MELD score >12.
- Alpha-1 antitrypsin deficiency.
- Current or recent history (< 5 years) of significant alcohol consumption. For men, significant consumption is defined as higher than 30g pure alcohol per day. For women, it is defined as higher than 20g pure alcohol per day.
- Compensated and decompensated cirrhosis (clinical and/or histological evidence of cirrhosis). Notably, NASH patients with fibrosis stage=4 according to the NASH CRN fibrosis staging system are excluded.
- Weight loss of more than 5 % within 6 months prior to randomization.
- Pregnant or breast feeding women or planning to become pregnant during the study period.
- Patients with a history of clinically significant acute cardiac event within 6 months prior to Screening such as: stroke, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- Known chronic heart failure (Grade I to IV of New York Heart Association classification).
- Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy.
- Fibrates are not permitted from 2 months before Randomization. Patients that used statins, ezetimibe, or fibrate lipid lowering drugs before Screening may participate if the dosage has been kept constant for at least 2 months prior to Screening.
- Patients with HbA1c >9.0%. If >9% at the first Screening Visit, the HbA1c measurement can be repeated at the latest 2 weeks prior to Randomization. A repeated abnormal HbA1c (HbA1c >9.0%) leads to exclusion.
- Patients receiving thiazolidinediones (glitazones [pioglitazone, rosiglitazone]), unless the drug was discontinued at least 6 months before the diagnostic liver biopsy.
- Patients receiving vitamin E, unless the drug was discontinued at least 6 months before the diagnostic liver biopsy.
- Currently taking drugs that can induce steatosis/steatohepatitis including, but not restricted to:corticosteroids (parenteral \& oral chronic administration only), amiodarone (Cordarone), tamoxifen (Nolvadex), and methotrexate (Rheumatrex, Trexall), which are not permitted 30 days prior to Screening and up to end of treatment.
- Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
- Evidence of any other unstable or, untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic, or psychiatric disease.
- Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
- Positive anti-human immunodeficiency virus (HIV) antibody.
- AST and/or ALT> 10x upper limit of normal (ULN).
- Conjugated bilirubin> 1.50 mg/dl due to altered hepatic function. Gilbert Disease patients are allowed into the study.
- INR>1.40.
- Platelet count < 100,000/mm3.
- Serum creatinine levels> 1.53 mg/dl in males and > 1.24 mg/dl in females.
- Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or eGFR of less than 60 ml/min/1.73m2).
- Unexplained serum CPK> 3x the ULN. In case of explained elevated CPK>3x the ULN, the measurement can be repeated prior to randomization. In this case, retest should be performed within 1 to 2 weeks after initial test. A CPK rates>3x ULN leads to exclusion.
- Use of anticoagulation or P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) therapy.
- Achalasia and any other esophageal motility disorders.
- Active severe esophagitis (grade C to D of Los Angeles Classification).
- Active gastric ulcer.
- Gastrointestinal stenosis or obstruction.
- Patients with contraindications to MRI imaging.
- Currently participating in another study.
- Previous bariatric surgery, or endoscopic obesity-related therapy such as endoscopic sleeve gastroplasty. Presence of intragastric balloon or retrieval within 6 months before signing informed consent.
- Immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CUB Hôpital Erasme
Brussels, 1070
Mia Persoons, 003225553016, mia.persoons@erasme.ulb.ac.be
Jacques Devière, MD, PhD
About this study
Official title: A Multicenter, Controlled Study to Evaluate the Efficacy and Safety of an Endoscopic Sutured Gastroplasty (With Endomina Device) in Patients With Non Alcoholic Steatohepatitis (NASH) and Fibrosis.
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver diseases characterized by liver steatosis which can, in a minority of patients, progress to nonalcoholic steatohepatitis (NASH), fibrosis, and ultimately hepatocellular carcinoma and liver failure. NASH is also recognized as an independent cardiovascular risk factor. Currently, weight loss is the only validated treatment for NASH and also positively affect all the features of metabolic syndrome. Considering the known positive metabolic effects of bariatric surgery, efforts have been exerted to develop minimally endoscopic procedures aiming to induce weight loss. Therefore, we would like to evaluate in patients with NASH disease and fibrosis, the impact of an endoscopic sutured gastroplasty (with Endomina® device) on:
- Mainly liver histological endpoints but also,
- Surrogate markers of hepatic inflammation and fibrosis and
- Surrogate markers of insulin resistance as well as fasting lipid and glycemic profiles.
Read the detailed description
Background and Rationale: Nonalcoholic steatohepatitis (NASH) is a chronic and progressive disease which can evolve to advanced fibrosis, cirrhosis, liver failure or liver cancer and is associated to a higher risk of death related mainly to cardiovascular events. Weight loss affects positively histological and metabolic features of NASH. Similarly, bariatric surgery improves NASH and fibrosis in morbidly obese patients. New medical devices have been developed to perform endoscopic sutured gastroplasty (ESG) in obese patients. Those affected with coexisting NASH might constitute a good indication for such procedure.
Objective: To determine whether ESG improves liver histology, defined as resolution of NASH without worsening of fibrosis at 48 weeks (primary outcome) after ESG.
Design, setting and participants: The ENDONASH trial is an investigator-initiated, randomized, controlled, European multicenter study with centrally blinded assessment of the primary outcome. Biopsy proven NASH patients will be randomly assigned (1:1) to either ESG associated to lifestyle intervention (LSI) or LSI alone using a computer-generated, centrally administered allocation, stratified by diabetes status, gender and fibrosis stage. Main inclusion criteria are: biopsy-proven NASH (i.e. Nonalcoholic Fatty Liver Disease Score ≥4), fibrosis stage ≥1, BMI between 27-40, controlled type 2 diabetes.
Sample size calculation: The study is powered to establish a 50% response rate of NASH resolution without worsening of fibrosis in the ESG group and a 10% response rate in the control group (according to our previous study1 and a study2 which has evaluated the impact of weight loss on NASH). Accepting an alpha risk of 0.05 (bilateral), a beta risk of 0.2 and a loss rate of 20%, a sample size of 100 patients is needed to achieve statistical significance. Analysis will be carried out by intention-to-treat analysis, which includes all patients who will undergo end-of treatment liver biopsy.
Procedures: Eligible patients will be allocated to one arm of the study by means of an online platform (ViedocTM). Demographics, anthropometric measurements, medical history, blood samples and transient elastography will be performed at baseline and at different time points after the randomization during the 48 weeks of follow-up. Finally, all patients will undergo an end-of treatment liver biopsy 48 weeks after randomization.
Conclusion: The expected conclusion will allow to demonstrate if ESG, as an add on to LSI, may increases the number of patients with resolution of NASH without worsening of fibrosis at one year.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- Endomina®
- 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.
Endomina®Device
Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Endomina procedure + lifestyle intervention | Experimental | The procedure will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over a guidewire and then fixed to the endoscope. This group will also receive the medical standard treatment defined as lifestyle intervention. Receives: Device: Endomina® |
| Lifestyle intervention | No intervention | The group will receive the medical standard treatment defined as lifestyle therapy combining diet (mediterranean diet) with increased physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disappearance of NASH without worsening of fibrosis grade
Diagnosis of NASH at the liver biopsy
Measured: at 48 weeks
Secondary outcomes (17)
Incidence of all Adverse Device Effects
Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
Measured: at 48 weeks
Change in th SF-46 quality of life score
SF-36 quality of life score
Measured: at 48 weeks
Change in the NAS (NAFLD activity score) score
NAS is a histological score established on the liver biopsy. The NAS ranges form 0 to 8. 8 is associated with the highest severity.
Measured: at 48 weeks
Change in liver histologic characteristics, such as steatosis, ballooning, lobular inflammation, and portal chronic inflammation scores.
Individual scores of the NAS score, the higher score (i.e. 8) means the worst condition.
Measured: at 48 weeks
Weight loss from randomization to the end of treatment
weight
Measured: at 48 weeks
Change in elastography measured by vibration-controlled transient elastography
Elastography is an indirect noninvasive measurement of liver fibrosis
Measured: at 48 weeks
Change in NAFLD fibrosis score
NAFLD fibrosis score is a non invasive biomarker of liver fibrosis, a score superior to 0,675 means the worst condition
Measured: at 48 weeks
Change in Alanine Transaminase (ALT)
ALT is a liver enzyme, used for the biological liver test evaluation.
Measured: at 48 weeks
Change in Aspartate Transaminase (AST)
AST is a liver enzyme, used for the biological liver test evaluation.
Measured: at 48 weeks
Change in metabolic profile assessed by HOMA score
HOMA is a score (scale) evaluating insulin resistance.
Measured: at 48 weeks
Change in Fasting glucose
fasting glucose is a marker of diabetes and insulin resistance
Measured: at 48 weeks
Change in Glycated haemoglobin
glycated haemoglobin is a surrogate marker for diabetes management and outcome.
Measured: at 48 weeks
Change in HDL cholesterol
HDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 48 weeks
Change in serum triglycerides
serum triglycerides is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 48 weeks
Change in LDL cholesterol
LDL cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 48 weeks
Change in total cholesterol.
total cholesterol is a biomarker for lipid metabolism and cardiovascular risk
Measured: at 48 weeks
Correlation between mediterranean diet score and NAS score change
Mediterranean diet assessment score evaluate the compliance to the mediterranean diet, the highest score (i.e.5) means the highest adherence
Measured: at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start23 Jun 2020
- Primary completion23 Jun 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Endomina procedure + lifestyle intervention Arm 2: Lifestyle intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Responsible party
- Sponsor
- Investigators
- Jacques Deviere, MD, phD, Principal investigator, CUB Hôpital Erasme, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653311
- Sponsor's protocol ID
- P2019/400 / B406201941027
- Acronym
- ENDONASH
- Status last verified
- Feb 2021
- First submitted
- 18 Aug 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Controlled Study to Evaluate the Efficacy and Safety of an Endoscopic Sutured Gastroplasty (With Endomina Device) in Patients With Non Alcoholic Steatohepatitis (NASH) and Fibrosis.
- ClinicalTrials.gov ID
- NCT04653311
- Acronym / sponsor ID
- ENDONASH / P2019/400 / B406201941027
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 23 Jun 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 4 Dec 2020 (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.
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver diseases characterized by liver steatosis which can, in a minority of patients, progress to nonalcoholic steatohepatitis (NASH), fibrosis, and ultimately hepatocellular carcinoma and liver failure. NASH is also recognized as an independent cardiovascular risk factor. Currently, weight loss is the only validated treatment for NASH and also positively affect all the features of metabolic syndrome. Considering the known positive metabolic effects of bariatric surgery, efforts have been exerted to develop minimally endoscopic procedures aiming to induce weight loss. Therefore, we would like to evaluate in patients with NASH disease and fibrosis, the impact of an endoscopic sutured gastroplasty (with Endomina® device) on:
- Mainly liver histological endpoints but also,
- Surrogate markers of hepatic inflammation and fibrosis and
- Surrogate markers of insulin resistance as well as fasting lipid and glycemic profiles.
Detailed description
Background and Rationale: Nonalcoholic steatohepatitis (NASH) is a chronic and progressive disease which can evolve to advanced fibrosis, cirrhosis, liver failure or liver cancer and is associated to a higher risk of death related mainly to cardiovascular events. Weight loss affects positively histological and metabolic features of NASH. Similarly, bariatric surgery improves NASH and fibrosis in morbidly obese patients. New medical devices have been developed to perform endoscopic sutured gastroplasty (ESG) in obese patients. Those affected with coexisting NASH might constitute a good indication for such procedure.
Objective: To determine whether ESG improves liver histology, defined as resolution of NASH without worsening of fibrosis at 48 weeks (primary outcome) after ESG.
Design, setting and participants: The ENDONASH trial is an investigator-initiated, randomized, controlled, European multicenter study with centrally blinded assessment of the primary outcome. Biopsy proven NASH patients will be randomly assigned (1:1) to either ESG associated to lifestyle intervention (LSI) or LSI alone using a computer-generated, centrally administered allocation, stratified by diabetes status, gender and fibrosis stage. Main inclusion criteria are: biopsy-proven NASH (i.e. Nonalcoholic Fatty Liver Disease Score ≥4), fibrosis stage ≥1, BMI between 27-40, controlled type 2 diabetes.
Sample size calculation: The study is powered to establish a 50% response rate of NASH resolution without worsening of fibrosis in the ESG group and a 10% response rate in the control group (according to our previous study1 and a study2 which has evaluated the impact of weight loss on NASH). Accepting an alpha risk of 0.05 (bilateral), a beta risk of 0.2 and a loss rate of 20%, a sample size of 100 patients is needed to achieve statistical significance. Analysis will be carried out by intention-to-treat analysis, which includes all patients who will undergo end-of treatment liver biopsy.
Procedures: Eligible patients will be allocated to one arm of the study by means of an online platform (ViedocTM). Demographics, anthropometric measurements, medical history, blood samples and transient elastography will be performed at baseline and at different time points after the randomization during the 48 weeks of follow-up. Finally, all patients will undergo an end-of treatment liver biopsy 48 weeks after randomization.
Conclusion: The expected conclusion will allow to demonstrate if ESG, as an add on to LSI, may increases the number of patients with resolution of NASH without worsening of fibrosis at one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: Endomina procedure + lifestyle intervention Arm 2: Lifestyle intervention
| Arm | Type | Receives |
|---|---|---|
| Endomina procedure + lifestyle intervention | Experimental | Device: Endomina®The procedure will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over a guidewire and then fixed to the endoscope. This group will also receive the medical standard treatment defined as lifestyle intervention. |
| Lifestyle intervention | No intervention | –The group will receive the medical standard treatment defined as lifestyle therapy combining diet (mediterranean diet) with increased physical activity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- BMI between 27 to 40 kg/m².
- Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to Screening or during the Screening Period) with at least 1 in each component of the NAS (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
- NAS ≥4.
- Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
- Patients in whom it is safe and practical to proceed with a liver biopsy (in accordance with the current guidelines), and who agree to have:
Key exclusion criteria (44 listed)
- Other well documented causes of chronic liver disease according to standard diagnostic procedures including, but not restricted to:
- Current or recent history (< 5 years) of significant alcohol consumption. For men, significant consumption is defined as higher than 30g pure alcohol per day. For women, it is defined as higher than 20g pure alcohol per day.
- Compensated and decompensated cirrhosis (clinical and/or histological evidence of cirrhosis). Notably, NASH patients with fibrosis stage=4 according to the NASH CRN fibrosis staging system are excluded.
- Weight loss of more than 5 % within 6 months prior to randomization.
- Pregnant or breast feeding women or planning to become pregnant during the study period.
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 |
|---|---|---|
| Endomina®Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year | Device | Endomina procedure + lifestyle intervention |
Primary outcome
Rate of disappearance of NASH without worsening of fibrosis grade
Time frame: at 48 weeks
Diagnosis of NASH at the liver biopsy
17 secondary outcomes
Incidence of all Adverse Device Effects
Time frame: at 48 weeks
Change in th SF-46 quality of life score
Time frame: at 48 weeks
Change in the NAS (NAFLD activity score) score
Time frame: at 48 weeks
Change in liver histologic characteristics, such as steatosis, ballooning, lobular inflammation, and portal chronic inflammation scores.
Time frame: at 48 weeks
Weight loss from randomization to the end of treatment
Time frame: at 48 weeks
Change in elastography measured by vibration-controlled transient elastography
Time frame: at 48 weeks
Change in NAFLD fibrosis score
Time frame: at 48 weeks
Change in Alanine Transaminase (ALT)
Time frame: at 48 weeks
Change in Aspartate Transaminase (AST)
Time frame: at 48 weeks
Change in metabolic profile assessed by HOMA score
Time frame: at 48 weeks
Change in Fasting glucose
Time frame: at 48 weeks
Change in Glycated haemoglobin
Time frame: at 48 weeks
Change in HDL cholesterol
Time frame: at 48 weeks
Change in serum triglycerides
Time frame: at 48 weeks
Change in LDL cholesterol
Time frame: at 48 weeks
Change in total cholesterol.
Time frame: at 48 weeks
Correlation between mediterranean diet score and NAS score change
Time frame: at 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Jacques Deviere, MD, phD principal investigator
CUB Hôpital Erasme, Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endomina® in people with NASH - Nonalcoholic Steatohepatitis, run by Erasme University Hospital at 1 site in Belgium.
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 15 inclusion and 44 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 2 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 Belgium. 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?
Contact Alia Hadefi, MD (+325553714 ext. 5718, alia.hadefi@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disappearance of NASH without worsening of fibrosis grade (time frame: at 48 weeks). 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 2 Feb 2021.