Actively Recruiting
Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
Led by Virginia Commonwealth University · Updated on 2026-04-02
240
Participants Needed
2
Research Sites
241 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with biopsy-confirmed or Agile F (F4) score > 0.45 cirrhosis
- NAFLD as cause of liver disease determined by either biopsy showing >5% steatosis, CAP > 280 dB/m, or MR-PDFF >5%
- If CAP < 280 dB/m or MR-PDFF <5%, must have type 2 diabetes or at least 2 metabolic syndrome features for 5 years (cryptogenic cirrhosis)
You will not qualify if you...
- Refusal to consent
- Alcohol use above 14 gm/week for women or 21 gm/week for men
- Other causes of chronic liver disease
- MELD score greater than 12
- Hepatic or extrahepatic cancers limiting life expectancy under 2 years
- Prior hepatic resections, TIPS, or splenic embolization
- Prior liver decompensation events
- Inability to fit into MRI machine (failed hula-hoop test)
- Contraindications to MRI contrast (GFR < 30 ml/min)
- Contraindications for MRI
- Pregnancy
- Acute kidney injury
- Reduced kidney function (GFR < 30 ml/min)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Mohammad S Siddiqui, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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