NCT05720663

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Apr 2023Dec 2027

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

January 31, 2023

Last Update Submit

April 1, 2026

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (4)

  • Number of deaths

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

    Up to 2 years

  • 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

  • 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

  • Hepatic Encephalopathy (HE)

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

    Up to 2 years

Secondary Outcomes (2)

  • Model For End-Stage Liver Disease (MELD) score

    Up to 2 years

  • Hepatocellular cancer (HCC)

    Up to 2 years

Study Arms (1)

nonalcoholic steatohepatitis (NASH)

Adult patients nonalcoholic steatohepatitis (NASH)

Other: Standard of care

Interventions

Standard of careOTHER

Participants will receive the standard of care for their condition

nonalcoholic steatohepatitis (NASH)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with presence of NAFLD associated cirrhosis.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mohammad S Siddiqui, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad S Siddiqui, MD

CONTACT

804-828-4060mohammad.siddiqui@vcuhealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

April 19, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 2, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)