Clinical Trials

Inclusion Criteria: 

• Adult patients with presence of NAFLD associated cirrhosis.
• Cirrhosis: biopsy confirmed or Agile F (F4) score > 0.45.
• NAFLD as the etiology of cirrhosis (any of the following below) 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)
• Rationale for Study Inclusion Criteria: The study will focus on stage 4 fibrosis (i.e. cirrhosis) because they have the highest unmet need. The F4 score is based on LSM, platelets, AST:ALT ratio, diabetes status and sex; many of these parameters are accepted by regulatory standards to represent a non-invasive diagnosis of cirrhosis (54). The attribution of NAFLD as cause of cirrhosis and criteria for cryptogenic cirrhosis meet regulatory standards and are accepted for inclusion in clinical trials (55). NIT-based diagnosis of cirrhosis is included to ensure that data are generalizable to populations seen in routine practice where biopsies are not done and diagnoses made with NIT.

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 in to MRI (failed hula-hoop test).
• Contraindications for MRI.
• General contraindication for MRI contrast (GFR < 30 ml/min).
• Pregnancy.

Rationale for exclusion criteria: The exclusion criteria are designed to meet ethical (refusal to consent), etiology (alcohol and other etiologies), clinical (factors likely to lead to death before a liver event e.g. cancers) and MRI-related (hula-hoop, GFR that precludes MRI) factors.

Eligibility last updated 7/27/22. Questions regarding updates should be directed to the study team contact.