NCT05720663Recruiting
Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 31 Jan 2023
- Start date
- 19 Apr 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05720663
What you commit to
- Study type: Observational
- Planned participants: 240
- From 19 Apr 2023 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior hepatic resections, TIPS, splenic embolization
- prior decompensation events
Other illness
- Other causes of chronic liver disease
Lab values
- general contraindication for MRI contrast (GFR \< 30 ml/min)
- reduced kidney function (GFR \<30ml/min)
Age
- Hepatic and extrahepatic cancers expected to limit life expectancy \< 2 yrs
Other
- Refusal to consent
- Alcohol use \> 14/21 gm/week cutoff
- MELD \> 12
- inability to fit into MRI (failed hula-hoop test)
- contraindications for MRI
- pregnancy
- acute kidney injury
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.