Decompensated Liver CirrhosisPhase 2NCT06764966
Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis
A Phase 2 study testing Atorvastatin 20 mg in people with Decompensated Liver Cirrhosis and Cirrhosis, run by CAMC Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Liver Cirrhosis, Cirrhosis, Decompensated Cirrhosis of Liver
- What is being tested?
- Atorvastatin 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to Mar 2027
- Phase
- Phase 2
- 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
Who may be able to join
- Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic
- Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.
Who cannot join
- Any patient <18 years of age
- Patients with hepatocellular carcinoma
- Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)
- Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence
- Patients currently on statin therapy
- Patients with a history of statin intolerance
Show all 9Show fewer
- Patients on the waitlist for liver transplantation
- Patients taking medications with known drug interactions with statins
- Patients not able to give informed consent or patients belonging to vulnerable categories as the Federal Regulations or Common Rule
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Charleston Area Medical Center
Charleston, West Virginia, 25304
Nadeem Anwar, MD, 304-351-1700, nadeem.anwar@vandaliahealth.org
Nadeem Anwar, MD
About this study
Official title: A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis
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.
- Conditions
- Decompensated Liver Cirrhosis, Cirrhosis, Decompensated Cirrhosis of Liver, Decompensated Cirrhosis and Ascites
- Being tested
- Atorvastatin 20 mg, Placebo
- Keywords
- Decompensated Cirrhosis, Decompensated Liver Disease, Statins, Beta-Blockers, Cirrhosis
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20 mgDrug
Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker
PlaceboDrug
Placebo Once Daily along with previously prescribed Non Selective Beta Blocker
| Study group | Role | What they receive |
|---|---|---|
| NSBB plus statin | Active comparator | Atorvastatin 20 mg once daily along with previously prescribed NSBB Receives: Drug: Atorvastatin 20 mg |
| NSBB plus placebo | Placebo comparator | Placebo once daily along with previously prescribed NSBB Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period
Measured: 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)
Measured: 12 months
Secondary outcomes (6)
Safety - Adverse events
Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other)
Measured: 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
Measured: 12 months
Hepatic transaminases levels
Number of participants with increases in transaminases by more than five times the upper limit of normal
Measured: 12 months
Survival rate
Rate of survival between the two treatment arms
Measured: 12 months
Transplant-free survival rate
Number of participants without liver transplant during study participation
Measured: 12 months
Rate of Hepatocellular Carcinoma Diagnosis
Number of participants developing Hepatocellular Carcinoma over 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start9 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Liver CirrhosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadeem Anwar, CAMC Health System
- Investigators
- Nadeem Anwar, MD, Principal investigator, CAMC Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764966
- Sponsor's protocol ID
- 24-1117
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT06764966
- Acronym / sponsor ID
- 24-1117
- Conditions
- Decompensated Liver Cirrhosis, Cirrhosis, Decompensated Cirrhosis of Liver, Decompensated Cirrhosis and Ascites
- Keywords
- Decompensated Cirrhosis, Decompensated Liver Disease, Statins, Beta-Blockers, Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSBB plus statin | Active comparator | Drug: Atorvastatin 20 mgAtorvastatin 20 mg once daily along with previously prescribed NSBB |
| NSBB plus placebo | Placebo comparator | Drug: PlaceboPlacebo once daily along with previously prescribed NSBB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic
- Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.
Key exclusion criteria (9 listed)
- Any patient <18 years of age
- Patients with hepatocellular carcinoma
- Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)
- Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence
- Patients currently on statin therapy
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 |
|---|---|---|
| Atorvastatin 20 mgAtorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker | Drug | NSBB plus statin |
| PlaceboPlacebo Once Daily along with previously prescribed Non Selective Beta Blocker | Drug | NSBB plus placebo |
Primary outcome
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
Time frame: 12 months
Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts)
6 secondary outcomes
Safety - Adverse events
Time frame: 12 months
New Decompensating events
Time frame: 12 months
Hepatic transaminases levels
Time frame: 12 months
Survival rate
Time frame: 12 months
Transplant-free survival rate
Time frame: 12 months
Rate of Hepatocellular Carcinoma Diagnosis
Time frame: 12 months
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 25 Feb 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.
Nadeem Anwar, MD principal investigator
CAMC Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 20 mg in people with Decompensated Liver Cirrhosis and Cirrhosis, run by CAMC Health System at 1 site 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 2 inclusion and 9 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nadeem Anwar, MD (304-351-1700, nadeem.anwar@vandaliahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period (time frame: 12 months). The study lists 2 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 25 Feb 2026.