Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Common statin may ward off liver failure in veterans

NCT ID NCT03654053

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether simvastatin, a drug typically used for cholesterol, can reduce the risk of liver complications in veterans with compensated cirrhosis (scarred but symptom-free liver). About 142 participants will take either simvastatin or a placebo nightly for several years. The goal is to see if the drug delays or prevents serious events like internal bleeding, fluid buildup, or liver cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Simvastatin
What this could lead to
If it works, this could show that a common cholesterol drug helps prevent serious liver complications in people with early-stage cirrhosis.
What could go wrong
This is a mid-stage trial with only 142 participants, all U.S. veterans, so results may not apply to everyone. Simvastatin can cause muscle pain or liver issues in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

142 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * U.S. Veteran * Cirrhosis due to chronic viral hepatitis, or alcohol or non-alcoholic fatty liver * Compensated cirrhosis (history of endoscopically-confirmed variceal hemorrhage, absence of overt ascites, history of overt non-precipitated encephalopathy) * Age \> 18 and \<= 80 * High risk of cirrhosis decompensation as defined by any of the following: * Presence of esophageal varices on endoscopy * Presence of portosystemic collaterals on imaging as determined by a body radiologist * Fibroscan VCTE \>= 20kPa * Platelet count \<= 125 K/mm * 44 total points (\~50% of clinically significant portal hypertension using the ANTICIPATE Nomogram) * Competent to provide informed consent Exclusion Criteria: * Prior exposure to any statin within 6 months * Prior allergy or sensitivity to simvastatin * History of variceal hemorrhage confirmed endoscopically within the previous 3 years * Presence of overt ascites or treatment with diuretics for ascites with 6 months * History of chronic, recurrent or episodic overt hepatic encephalopathy with asterixis within 6 months * History of hepatocellular carcinoma * Child-Turcotte-Pugh C Stage (CTP Score \> 9) * Prior receipt of organ transplant * Participation in another pharmacological clinical trial within 3 months of the current study * Pregnancy or anticipated pregnancy within 2 years * Breast Feeding * Patients with life expectancy \< 3 years due to comorbid conditions * Independent indication for initiation of statin therapy * Patients with any form of clinical atherosclerotic cardiovascular disease (ASCVD) * Patients with primary LDL-C \< 190 mg/dl * Patients with diabetes mellitus, age 40-75 years, with LDL-C levels \>=130 mg/dl * Need for concomitant administration of potent inhibitors of CYP34A4 enzymes (medications or other supplements that should not be taken with simvastatin, including cyclosporine, danazol, gemfibrozil, fenofibrate, extended release niacin, itraconazole, ketoconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, macrolide antibiotics - erythromycin, clarithromycin, telithromycin, nefazadone, amlodipine, verapamil, diltiazem, dronedarone, amiodarone, renolazine, lomitapide, and cobicistat) * Prior TIPSS shunt * Hemodialysis

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cirrhosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis

Contacts and locations

Locations

  • Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY

    Brooklyn, New York, 11209, United States

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

    Philadelphia, Pennsylvania, 19104-4551, United States

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249, United States

  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030, United States

  • Philadelphia MultiService Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19106, United States

  • Robley Rex VA Medical Center, Louisville, KY

    Louisville, Kentucky, 40206, United States

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California, 94121, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130, United States

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516, United States

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

    Seattle, Washington, 98108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.