About this trial
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.
Eligibility criteria
Qualifiers
Cirrhosis: biopsy confirmed or Agile F (F4) score > 0.45
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)
Disqualifiers
Refusal to consent
Alcohol use > 14/21 gm/week cutoff
Other causes of chronic liver disease
MELD > 12
Trial design
Treatments tested in this trial
- Standard of care
Treatment groups
Sponsors and collaborators
Virginia Commonwealth University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator