Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05623150 Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Condition: Non-Alcoholic Fatty Liver Disease
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Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05623150
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older.
  • People who are registered with the French social security system.
  • People who are able to understand information about the research and sign a written consent form.
  • People in the fatty liver disease (NAFLD) group with liver cancer: those whose alcohol intake is below certain weekly limits (up to 210g of pure alcohol per week for men, or 140g per week for women), who have had a decision made within the last 3 months to have a liver biopsy of a suspected liver cancer nodule as part of routine care, and who have not received any systemic (whole-body) treatment for liver cancer in the past 6 months.
  • People in the fatty liver disease (NAFLD) group without liver cancer: those whose alcohol intake is below the same weekly limits above, and who have had a decision made within the last 3 months to have a routine liver biopsy, prompted by abnormal liver test results and/or fatty changes seen on ultrasound.
  • People in the alcohol-related liver disease group with liver cancer: those whose alcohol intake exceeds the weekly limits above (or who engage in binge drinking), who have had a decision made within the last 3 months to have a routine liver biopsy of a suspected liver cancer nodule, and who have not received any systemic treatment for liver cancer in the past 6 months.
  • People in the alcohol-related liver disease group without liver cancer: those whose alcohol intake exceeds the weekly limits above (or who engage in binge drinking), and who have had a decision made within the last 3 months to have a routine liver biopsy, prompted by abnormal liver test results and/or fatty changes seen on ultrasound.

Who may not be able to join:

  • People who have tested positive for HIV.
  • People who have a detectable level of the hepatitis C virus in their blood.
  • People who carry the hepatitis B surface antigen (a marker indicating hepatitis B infection).
  • People with a history of certain liver conditions, including autoimmune hepatitis (type 1 or 2), primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, a specific inherited form of iron overload (homozygous genetic haemochromatosis), or alpha-1 antitrypsin deficiency.
  • People who have been taking certain long-term medications, including methotrexate, corticosteroids, anti-TNF drugs, cyclosporine, or tacrolimus.
  • People who have previously had a solid organ transplant (such as a kidney or heart) or a bone marrow transplant.
  • People who are currently receiving treatment for a cancer other than certain skin cancers (melanoma is not included in this exception).
  • People who are under legal protection or are otherwise unable to give their own consent.
  • Women who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 0033492035943

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Registry
ClinicalTrials.gov
Start date
6 December 2022
Est. completion
1 January 2032

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Primary outcome measure CHALNA2

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov