Nonalcoholic SteatohepatitisNCT05720663
Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
An observational study of Nonalcoholic Steatohepatitis, run by Virginia Commonwealth University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with presence of NAFLD associated cirrhosis.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Mohammad Siddiqui, MD, 804-828-4060, mohammad.siddiqui@vcuhealth.org
Mohammad Siddiqui, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Christopher Kigongo, 507-266-1998, Kigongo.Christopher@mayo.edu
Mia Mahmoud, 507-284-0361, Mahmoud.Mia@mayo.edu
About this study
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.
Read the detailed 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.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- Standard of care
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Participants will receive the standard of care for their condition
| Study group | Role | What they receive |
|---|---|---|
| nonalcoholic steatohepatitis (NASH) | Adult patients nonalcoholic steatohepatitis (NASH) Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deaths
Number of deaths will be determined from death records and patient charts.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Hepatic Encephalopathy (HE)
Number of grade 2, 3, or 4 HE events will be assessed by clinician during exams.
Measured: Up to 2 years
Secondary outcomes (2)
Model For End-Stage Liver Disease (MELD) score
Number of participants with MELD scores greater than 15
Measured: Up to 2 years
Hepatocellular cancer (HCC)
Number of participants with HCC
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start19 Apr 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad S Siddiqui, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720663
- Sponsor's protocol ID
- HM20024296
- Other IDs
- 1R01DK129564
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
- ClinicalTrials.gov ID
- NCT05720663
- Acronym / sponsor ID
- HM20024296
- Conditions
- Nonalcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nonalcoholic steatohepatitis (NASH) | – | Other: Standard of careAdult patients nonalcoholic steatohepatitis (NASH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with presence of NAFLD associated cirrhosis.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careParticipants will receive the standard of care for their condition | Other | nonalcoholic steatohepatitis (NASH) |
Primary outcome
Number of deaths
Time frame: Up to 2 years
Number of deaths will be determined from death records and patient charts.
Incidents of variceal hemorrhage
Time frame: Up to 2 years
Number of participants showing bleeding from abnormal vessels in the liver called varices will be assessed using an endoscopy exam.
Incidents of ascites
Time frame: Up to 2 years
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.
Hepatic Encephalopathy (HE)
Time frame: Up to 2 years
Number of grade 2, 3, or 4 HE events will be assessed by clinician during exams.
2 secondary outcomes
Model For End-Stage Liver Disease (MELD) score
Time frame: Up to 2 years
Hepatocellular cancer (HCC)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad S Siddiqui, MD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Steatohepatitis, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad S Siddiqui, MD (804-828-4060, mohammad.siddiqui@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.