Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT05720663

Conditions

Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of care

Study Details

Brief summary:

Nonalcoholic Steatohepatitis (NASH) is a condition with increased amount of fat, inflammation and scarring in the liver. In compensated cirrhosis, the liver is coping with this damage and maintaining its important functions. Decompensation occurs when the liver becomes unable to perform all of its functions adequately. Variceal hemorrhage (bleeding from abnormal vessels in the liver called varices), Ascites (abnormal build-up of fluid in the abdomen), and Encephalopathy (brain confusion as a result of the liver not being able to get rid of toxic substances) are three symptoms of liver decompensation.

The purpose of this research study is to investigate better ways to routinely monitor the condition of patients with NASH with compensated cirrhosis and to better pinpoint the development of decompensation in the livers of these patients.

Conditions

Nonalcoholic Steatohepatitis

Study ID

NCT05720663

Start date

Apr 19, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adult patients with presence of NAFLD associated cirrhosis.

  • 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 Criteria:

  • 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)

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

nonalcoholic steatohepatitis (NASH)

Adult patients nonalcoholic steatohepatitis (NASH)

Interventions

Standard of care

Participants will receive the standard of care for their condition

Primary outcome measure

  • Number of deaths [ Time Frame: Up to 2 years ]
  • Incidents of variceal hemorrhage [ Time Frame: Up to 2 years ]
  • Incidents of ascites [ Time Frame: Up to 2 years ]
  • Hepatic Encephalopathy (HE) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Mohammad S Siddiqui, MD

804-828-4060mohammad.siddiqui@vcuhealth.org

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Christopher Kigongo

507-266-1998Kigongo.Christopher@mayo.edu

Mia Mahmoud

507-284-0361Mahmoud.Mia@mayo.edu

Principal Investigator:

Manal F. Abdelmalek, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Mohammad Siddiqui, MD

804-828-4060mohammad.siddiqui@vcuhealth.org

Principal Investigator:

Mohammad Siddiqui, MD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Apr 2, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-04-02.