Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at patients with a liver condition called Nonalcoholic Steatohepatitis (NASH), which is characterized by fat buildup, inflammation, and scarring in the liver. Specifically, the study aims to find better ways to monitor patients who have compensated cirrhosis—a stage where the liver is still functioning, despite damage. Researchers want to identify when patients might experience worsening symptoms, known as decompensation, which can lead to serious issues like bleeding, fluid build-up in the abdomen, or confusion due to toxins not being cleared from the body.

To participate in the trial, patients need to be adults who have been diagnosed with cirrhosis related to NASH, confirmed through a liver biopsy or specific tests. They should also meet certain health criteria and not have other serious liver diseases or conditions that could affect their eligibility. Participants will undergo various assessments to help researchers understand how to better track changes in liver health. It’s important to know that if you have any severe health issues, such as certain cancers or kidney problems, you may not qualify for this study.

Gender

ALL

Eligibility criteria

• 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)