Simvastatin for Liver Cirrhosis
(SACRED Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byDavid E Kaplan, MD MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: VA Office of Research and Development

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

David E Kaplan, MD MSc

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Eligibility Criteria

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.

Inclusion Criteria

I am at high risk for my liver condition getting worse.

I have cirrhosis caused by hepatitis, alcohol, or fatty liver disease.

My liver disease is stable with specific health criteria met.

See 3 more

Exclusion Criteria

I have had liver cancer in the past.

Patients with life expectancy < 3 years due to comorbid conditions

My liver disease is severe (CTP Score > 9).

See 16 more

Treatment Details

Interventions

Simvastatin (Statin)

Trial OverviewThe 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.

Participant Groups

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.

Simvastatin is already approved in Canada, Japan for the following indications: