NCT05720663 Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis
| NCT ID | NCT05720663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | Nonalcoholic Steatohepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-04-19 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2023-04-19 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Mohammad S Siddiqui, MD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT05720663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nonalcoholic Steatohepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05720663 currently recruiting?
Yes, NCT05720663 is actively recruiting participants. Contact the research team at mohammad.siddiqui@vcuhealth.org for enrollment information.
Where is the NCT05720663 trial being conducted?
This trial is being conducted at Rochester, United States, Richmond, United States.
Who is sponsoring the NCT05720663 clinical trial?
NCT05720663 is sponsored by Virginia Commonwealth University. The principal investigator is Mohammad S Siddiqui, MD at Virginia Commonwealth University. The trial plans to enroll 240 participants.