A Phase 2 interventional study of Atorvastatin 20 mg and Placebo in Decompensated Liver Cirrhosis, Cirrhosis and Decompensated Cirrhosis of Liver, sponsored by CAMC Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by CAMC Health System · Phase 2, Interventional, and Treatment
Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 50 is close to the median of 54 across 179 interventional studies indexed under Ascites.
Browse Ascites studies →CAMC Health System is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Compared within Ascites, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Atorvastatin 20 mg once daily along with previously prescribed NSBB
Drug: Atorvastatin 20 mg
Placebo once daily along with previously prescribed NSBB
Drug: Placebo
Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker
Placebo Once Daily along with previously prescribed Non Selective Beta Blocker
Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period
Time frame: 12 months
Feasibility- compare the number of participants compliant with study treatment
Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts)
Time frame: 12 months
Safety - Adverse events
Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other)
Time frame: 12 months
New Decompensating events
Rate of new decompensating events (ascites, vatical bleeding, worsening jaundice, or encephalopathy) in each arm, time for development of new decompensating event
Time frame: 12 months
Hepatic transaminases levels
Number of participants with increases in transaminases by more than five times the upper limit of normal
Time frame: 12 months
Survival rate
Rate of survival between the two treatment arms
Time frame: 12 months
Transplant-free survival rate
Number of participants without liver transplant during study participation
Time frame: 12 months
Rate of Hepatocellular Carcinoma Diagnosis
Number of participants developing Hepatocellular Carcinoma over 12 months
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Mar 2027, 18 months after the start.
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Studies of the drug tested here: Atorvastatin
CAMC Health System