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Statin

Simvastatin for Liver Cirrhosis (SACRED Trial)

Q: Is this the initial research study of its type?

<p>Merck Sharp &#x26; Dohme LLC first sponsored a study for Simvastatin 40mg in 2005. Since the initial Phase 4 drug approval in 2005, 37 clinical trials have been conducted in 31 countries and 239 cities.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

SACRED Trial Summary

This trial will test whether simvastatin can lower the risk of hepatic decompensation in people with compensated cirrhosis. It will also explore how changes in genes effect the safety and effectiveness of using statins and how the use of statins affects quality of life.

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.Check my eligibility

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.See study design

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.

SACRED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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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.

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I am between 18 and 80 years old.

SACRED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Survival free from hepatic decompensation

Secondary outcome measures

Change in patient health-related quality of life

Hepatotoxicity

Liver-related death

+4 more

SACRED 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,461 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

Simvastatin (Statin) Clinical Trial Eligibility Overview. Trial Name: NCT03654053 — Phase 3

Liver Cirrhosis Research Study Groups: Simvastatin, Placebo

Liver Cirrhosis Clinical Trial 2023: Simvastatin Highlights & Side Effects. Trial Name: NCT03654053 — Phase 3

Simvastatin (Statin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03654053 — Phase 3

Liver Cirrhosis Patient Testimony for trial: Trial Name: NCT03654053 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are currently conducting this experiment?

"To make the enrollment process as smooth as possible for patients, the trial is running at 11 sites which are located in or near large cities. If you enroll in the trial, the location of the trial nearest you will be selected to minimize patient travel."

Answered by AI

What conditions does Simvastatin 40mg usually help alleviate?

"By prescription, Simvastatin 40mg can be used to lower cholesterol levels, treat diabetes mellitus, and prevent cardiovascular events."

Answered by AI

Is this the initial research study of its type?

"Merck Sharp & Dohme LLC first sponsored a study for Simvastatin 40mg in 2005. Since the initial Phase 4 drug approval in 2005, 37 clinical trials have been conducted in 31 countries and 239 cities."

Answered by AI

What does the research say about Simvastatin 40mg's efficacy?

"The first trial for Simvastatin 40mg took place in 2005 at OHSU Hospital. 464 trials have completed since then. Out of the 37 active clinical trials, a large number of them are being conducted in San Francisco, California."

Answered by AI

Are new patients needed for this trial at this time?

"Yes, this particular clinical trial is still running and actively recruiting patients. The trial was first posted on October 2nd, 2020 and the latest update was on June 16th, 2022."

Answered by AI

If a patient is not yet 65, can they join this particular clinical trial?

"Eligible participants for this clinical trial must be between the ages of 18 and 80."

Answered by AI

Is there a danger in taking Simvastatin 40mg daily?

"Simvastatin 40mg received a safety score of 3 because there is Phase 3 clinical trial data supporting both its efficacy and safety."

Answered by AI

Who else is applying?

What state do they live in?

Washington

Pennsylvania

Texas

Other

How old are they?

18 - 65

What site did they apply to?

San Francisco VA Medical Center, San Francisco, CA

Other

Robley Rex VA Medical Center, Louisville, KY

VA Puget Sound Health Care System Seattle Division, Seattle, WA

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I was told I have stage 4 cirrhosis. Anything to help.My Dr is Dr Machicao at Memorial Herman.

PatientReceived 2+ prior treatments

Other than Nadolol and just this week, a statin drug, I've not been prescribed any medications regarding my Cirrhosis. This along with losing weight and taking supplements are what I've been doing to try and stop the progression of liver scarring. I'm hoping a drug like Simvastatin would be the answer to halting future scarring and allow me to live a full life.

PatientReceived 2+ prior treatments

Recently I learned from a research protocol that my liver had become fibrotic. i am taking 4 ursodials a day and maybe that needs to be changed. i see the doctor on 5/29 and will ask if she thinks it is a good idea. maybe i can help someone else. Dr. Gish had me on rotating antibiotics for about 5 years and i stayed at the same level for about 15 years. dr. ky will probably order a biospy because it is time. once we know the status we will move forward. i recently did a rash survey and my skin is much better but that ends on 4/23. i did not realize the ease of the itch was possible. i wonder what else is available.

PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long will the trail go for and would I be prescribed the medication or is there a chance I would be getting a placebo? How often would I be required to travel to Louisville during the trial? Once the trail is completed and provided Simvastatin results are positive would the drug still be available to me?

PatientReceived no prior treatments