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Statin
Simvastatin for Liver Cirrhosis (SACRED Trial)
Phase 3
Waitlist Available
Led By David E. Kaplan, MD MSc
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High risk of cirrhosis decompensation as defined by specific criteria
Cirrhosis due to chronic viral hepatitis, alcohol, or non-alcoholic fatty liver
Must not have
History of hepatocellular carcinoma
Child-Turcotte-Pugh C Stage (CTP Score > 9)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Pivotal Trial
Summary
This trial tests if simvastatin can prevent serious liver problems in U.S. Veterans with early-stage liver damage. Simvastatin not only lowers cholesterol but also helps protect the liver from further damage and reduces the risk of severe liver issues. Statins, including simvastatin, have been increasingly recognized for their potential benefits in treating chronic liver diseases, including cirrhosis, by reducing portal pressure and protecting against liver damage.
Who is the study for?
This trial is for U.S. Veterans aged 18-80 with compensated cirrhosis, indicated by specific liver conditions and test results. Participants must not have had certain complications like overt ascites or hepatic encephalopathy recently, no history of hepatocellular carcinoma, and should not be on conflicting medications or have other severe health issues.
What is being tested?
The study tests if Simvastatin (40mg), a drug normally used to lower cholesterol, can prevent worsening symptoms in patients with high-risk compensated cirrhosis compared to a placebo. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real medicine.
What are the potential side effects?
Simvastatin may cause muscle pain or weakness, liver enzyme changes leading to potential liver damage, digestive problems like constipation or nausea, increased blood sugar levels which could lead to diabetes risk increase.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at high risk for my liver condition getting worse.
Select...
I have cirrhosis caused by hepatitis, alcohol, or fatty liver disease.
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My liver disease is stable with specific health criteria met.
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I understand and can agree to the study's procedures and risks.
Select...
I am between 18 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had liver cancer in the past.
Select...
My liver disease is severe (CTP Score > 9).
Select...
I have had episodes of severe liver-related brain dysfunction in the last 6 months.
Select...
I need to start taking statins for my health.
Select...
I have a condition related to the hardening of my arteries.
Select...
I need to take strong medication that affects liver enzymes.
Select...
I am on hemodialysis.
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I am between 40-75 years old, have diabetes, and my LDL cholesterol is 130 mg/dl or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Survival free from hepatic decompensation
Secondary study objectives
Change in patient health-related quality of life
Hepatotoxicity
Liver-related death
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SimvastatinExperimental Treatment1 Intervention
Simvastatin 40mg PO once at bedtime for up to 24 months. Note: all enrolled subjects will trial 20mg once at bedtime for two weeks as lead-in to determine tolerability prior to randomization.
Group II: PlaceboPlacebo Group1 Intervention
Placebo 40mg PO once at bedtime for up to 24 months. Note: all enrolled subjects will trial 20mg once at bedtime for two weeks as lead-in to determine tolerability prior to randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin 40mg
2018
Completed Phase 2
~160
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Statins, such as simvastatin, are commonly used in the treatment of liver cirrhosis due to their ability to inhibit HMG-CoA reductase, an enzyme crucial for cholesterol synthesis. By lowering cholesterol levels, statins help reduce liver inflammation and fibrosis, which are key factors in the progression of cirrhosis.
Moreover, statins have been associated with a decreased risk of hepatic decompensation and hepatocellular carcinoma, making them valuable in improving liver function and reducing complications in cirrhosis patients.
SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation.An Evidence-Based Review of Statin Use in Patients With Nonalcoholic Fatty Liver Disease.
SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation.An Evidence-Based Review of Statin Use in Patients With Nonalcoholic Fatty Liver Disease.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,653 Previous Clinical Trials
3,360,813 Total Patients Enrolled
3 Trials studying Liver Cirrhosis
200 Patients Enrolled for Liver Cirrhosis
David E. Kaplan, MD MScPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at high risk for my liver condition getting worse.I am between 18 and 80 years old.I have cirrhosis but it's under control and I've had variceal bleeding.I have had liver cancer in the past.My liver disease is severe (CTP Score > 9).You have a VCTE of at least 20kPa.I have cirrhosis caused by hepatitis, alcohol, or fatty liver disease.My liver disease is stable with specific health criteria met.I have had fluid in my abdomen or been treated for it in the last 6 months.I have had episodes of severe liver-related brain dysfunction in the last 6 months.I need to start taking statins for my health.I have a condition related to the hardening of my arteries.I need to take strong medication that affects liver enzymes.I am on hemodialysis.I am between 40-75 years old, have diabetes, and my LDL cholesterol is 130 mg/dl or higher.I haven't taken any statin drugs in the last 6 months.I understand and can agree to the study's procedures and risks.I am between 18 and 80 years old.Presence of portosystemic collaterals on imaging as determined by a body radiologist.I have cirrhosis caused by hepatitis, alcohol, or fatty liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Simvastatin
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Liver Cirrhosis Patient Testimony for trial: Trial Name: NCT03654053 — Phase 3
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