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Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

This study is for adults with Nonalcoholic Steatohepatitis (NASH), a liver condition with fat, inflammation, and scarring, who also have compensated cirrhosis (meaning your liver is still working well despite damage). We want to find better ways to predict when the liver might stop working as well, a process called decompensation. Symptoms of decompensation include bleeding from abnormal blood vessels (variceal hemorrhage) or fluid buildup in the belly (ascites). You will receive your usual medical care. We will also look at how well three additional procedures, beyond routine blood tests, can help us predict these outcomes. The study aims to see how many people experience variceal hemorrhage, ascites, or death over up to two years.

Study design
This is an observational study, meaning participants will receive standard medical care. It plans to enroll 240 participants.
What's involved
Aside from current routine procedures including blood draws, this study will check to see how effectively adding three additional procedures will help predict development of liver decompensation.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to two years to track outcomes like variceal hemorrhage, ascites, and death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05720663

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Recruiting
Not specifiedAges 18+Observational
Virginia Commonwealth University
~240 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:Standard of care

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of deaths
Measured over Up to 2 years
+3 more outcomes measured

Conditions

Nonalcoholic Steatohepatitis

Explore related trials

Nonalcoholic Steatohepatitis

NCT05720663

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mohammad S Siddiqui, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Mohammad S Siddiqui, MD
[email protected]
804-828-4060
Email the study team

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Eligibility criteria

Inclusion

Cirrhosis: biopsy confirmed or Agile F (F4) score \> 0.45
NAFLD as an etiology of liver disease will be determined based on presence of any of the following:
Biopsy showing \>5% steatosis or
CAP \> 280 dB/m or MR-PDFF\>5%
If CAP \< 280 dB/m or MR-PDFF \<5%, then must have type 2 diabetes and or 2 or more features of metabolic syndrome for 5 years (cryptogenic cirrhosis)

Exclusion

Refusal to consent
Alcohol use \> 14/21 gm/week cutoff
Other causes of chronic liver disease
MELD \> 12
Hepatic and extrahepatic cancers expected to limit life expectancy \< 2 yrs
prior hepatic resections, TIPS, splenic embolization
prior decompensation events
inability to fit into MRI (failed hula-hoop test)
general contraindication for MRI contrast (GFR \< 30 ml/min)
contraindications for MRI
pregnancy
acute kidney injury
reduced kidney function (GFR \<30ml/min)

What this trial measures

  • Number of deathsUp to 2 years

    Number of deaths will be determined from death records and patient charts.

  • Incidents of variceal hemorrhageUp to 2 years

    Number of participants showing bleeding from abnormal vessels in the liver called varices will be assessed using an endoscopy exam.

  • Incidents of ascitesUp to 2 years

    Number of participants with experiencing abnormal build-up of fluid in the abdomen will be assessed using a clinical exam including an ultrasound graded per clinical standards.

  • Hepatic Encephalopathy (HE)Up to 2 years

    Number of grade 2, 3, or 4 HE events will be assessed by clinician during exams.