Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

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

240 Participants
are divided into 1 treatment group

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator