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Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

ConditionNonalcoholic Steatohepatitis
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

This trial does not accept healthy volunteers

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 population

Adult patients with presence of NAFLD associated cirrhosis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard of care

    Other intervention

    Participants will receive the standard of care for their condition

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: nonalcoholic steatohepatitis (NASH)1 intervention

Trial outcomes

Primary outcomes

1

Number of deaths

Number of deaths will be determined from death records and patient charts.

Time frame
Up to 2 years
2

Incidents of variceal hemorrhage

Number of participants showing bleeding from abnormal vessels in the liver called varices will be assessed using an endoscopy exam.

Time frame
Up to 2 years
3

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.

Time frame
Up to 2 years
4

Hepatic Encephalopathy (HE)

Number of grade 2, 3, or 4 HE events will be assessed by clinician during exams.

Time frame
Up to 2 years

Secondary outcomes

1

Model For End-Stage Liver Disease (MELD) score

Number of participants with MELD scores greater than 15

Time frame
Up to 2 years
2

Hepatocellular cancer (HCC)

Number of participants with HCC

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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