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Digital biopsy score may predict liver failure risk in fatty liver patients

NCT ID NCT06493253

Knowledge-focused Sponsor: PharmaNest, Inc Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study looked at whether a computer analysis of liver biopsy images (called FibroNest Ph-FCS) can predict future liver complications in people with a type of fatty liver disease called MASLD. Researchers reviewed medical records from 1,578 patients to see if the digital score was better at forecasting liver-related events than standard methods. No new treatments were tested; the goal was to confirm the test's accuracy as a prognostic tool.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,519 people

The number who actually took part.

Started

Sep 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient from the NAFLD Adult Database 2 Registry including Adult pts ( \>=18 years old) with MASLD defined histologically with \>1 year of clinical follow up and available recording liver-related outcomes through clinical observation.

Ages

18 to 90 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

From NCT01030484: * Age at least 18 years during the consent process * Willingness to be in the study for 1 or more years * Ability and willingness to give written, informed consent to be screened for and, if eligible, to be enrolled into the Database 2 study * Minimal or no alcohol use history consistent with NAFLD (see exclusion criteria) * Collection of a liver biopsy that is obtained within 120 days of enrollment as part of standard of care or for evaluation in FLINT trial * Collection of biosamples (serum, plasma, DNA, and, if available, liver tissue) within 90 days prior to enrollment and 0-90 days before or 4-90 days after the standard of care liver biopsy Exclusion Criteria: From NCT01030484 * Clinical or histological evidence of alcoholic liver disease or alcohol consumption during the two years before entry (\> 20g/day for men, \>10g/day women) * History of total parenteral nutrition * History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD * Biliopancreatic diversion or bariatric surgery * Evidence of advanced liver disease with Child-Pugh-Turcotte score equal to or greater than 10 * Short bowel syndrome * Suspected or confirmed hepatocellular carcinoma * Positive for HIV * Evidence of HBV or HCV infection * Low alpha-1-antitrypsin level and ZZ phenotype * Wilson's disease * Known glycogen storage disease, dysbetalipoproteinemia, phenotypic hemochromatosis * Vascular lesions * Iron overload greater than 3+ * Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis * Multiple epithelioid granulomas * Congenital hepatic fibrosis * Polycystic liver disease * Other metabolic or congenital liver disease

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic dysfunction-associated steatotic liver disease

Contacts and locations

Locations

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

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