Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Virginia Commonwealth University
Study ID
NCT05720663
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of care — OTHER
    Participants will receive the standard of care for their condition

Study Details

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.

Key Dates

Start date
Apr 19, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: nonalcoholic steatohepatitis (NASH)
    Adult patients nonalcoholic steatohepatitis (NASH)

Primary Outcome Measure

Number of deaths [ Time Frame: Up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Christopher Kigongo
[email protected]
507-266-1998
Mia Mahmoud
[email protected]
507-284-0361
Manal F. Abdelmalek, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Mohammad Siddiqui, MD
[email protected]
804-828-4060
Mohammad Siddiqui, MD (PRINCIPAL_INVESTIGATOR)

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