Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720663
• Other study ID #: HM20024296
• Secondary ID: 1R01DK129564
• Status: Recruiting
• Start date: April 19, 2023
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Virginia Commonwealth University
• Contact: Mohammad S Siddiqui, MD
• Phone: 804-828-4060
• Email: mohammad.siddiqui[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This clinical research study is done to investigate better ways to routinely monitor the condition of patients with Nonalcoholic Steatohepatitis (NASH) with compensated cirrhosis. The purpose of this study is to better pinpoint the development of decompensation in the livers of these patients (some symptoms are variceal hemorrhage, ascites, and encephalopathy, defined below).

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.

Aside from current routine procedures including blood draws, this study will check to see how effectively adding three additional procedures will help predict development of liver decompensation. These additional procedures are Spleen Stiffness Measurement (SSM) during a special liver ultrasound called a Fibroscan, an imagining scan called Magnetic Resonance Imagining (MRI) using a contrast agent called Gadoxetate Sodium to highlight cirrhosis, and an MRI scan called metabophenotype, which examines muscle composition of the liver.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Other:
• Standard of care
Participants will receive the standard of care for their condition

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of deaths	Number of deaths will be determined from death records and patient charts.	Up to 2 years
Primary	Incidents of variceal hemorrhage	Number of participants showing bleeding from abnormal vessels in the liver called varices will be assessed using an endoscopy exam.	Up to 2 years
Primary	Incidents of ascites	Number of participants with experiencing abnormal build-up of fluid in the abdomen will be assessed using a clinical exam including an ultrasound graded per clinical standards.	Up to 2 years
Primary	Hepatic Encephalopathy (HE)	Number of grade 2, 3, or 4 HE events will be assessed by clinician during exams.	Up to 2 years
Secondary	Model For End-Stage Liver Disease (MELD) score	Number of participants with MELD scores greater than 15	Up to 2 years
Secondary	Hepatocellular cancer (HCC)	Number of participants with HCC	Up to 2 years