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HMG-CoA Reductase Inhibitor

Simvastatin for Preventing Liver Cancer in Patients With Cirrhosis

Q: What makes this trial unique in comparison to others?

<p>Merck Sharp &#x26; Dohme LLC sponsored the first study of simvastatin in 2005, which involved 80 patients. Since this initial clinical trial, there have been 37 more studies conducted globally across 239 cities and 31 countries.</p>

Q: What are the cholesterol-lowering capabilities of Simvastatin?

<p>Simvastatin is useful in the management of <a href="https://www.withpower.com/clinical-trials/cholesterol">cholesterol</a>, <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> mellitus, and as a prophylactic measure against <a href="https://www.withpower.com/clinical-trials/cardiovascular">cardiovascular</a> events.</p>

Phase 2

Waitlist Available

Led By Marc T Goodman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

Study Summary

This trial will study how well simvastatin works in preventing liver cancer in patients with liver cirrhosis.

Who is the study for?

Adults with liver cirrhosis who are not pregnant or breastfeeding, have not had a liver transplant or certain cancers, and do not drink excessively can join. They must be in fairly good health otherwise, with specific blood test results within acceptable ranges and able to use birth control if necessary.Check my eligibility

What is being tested?

The trial is testing whether simvastatin can prevent liver cancer in patients with liver cirrhosis. Participants will either receive simvastatin or a placebo while undergoing regular monitoring through imaging tests like CT scans and MRIs, as well as providing biospecimens.See study design

What are the potential side effects?

Simvastatin may cause muscle pain, digestive issues, increased blood sugar levels, and memory problems or confusion. It's also important for women to know that it could harm an unborn baby if they become pregnant during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 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

Change in serum AFP-L3%

Secondary outcome measures

Change in Model for End-Stage Liver Disease score

Change in fibrosis 4 index score

Liver

+3 more

Other outcome measures

Change in serum bile acids

Change in serum immune markers

Side effects data

From 2015 Phase 3 trial • 33 Patients • NCT02030041

11%

Myalgia

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin D and Placebo

Simvastatin and Placebo

Simvastatin and Vitamin D

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group I (simvastatin)Experimental Treatment5 Interventions

Patients receive simvastatin PO QD. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood on study and CT/MRI throughout the trial.

Group II: Group II (placebo)Placebo Group5 Interventions

Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood on study and CT/MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Simvastatin

2012

Completed Phase 4

~1270

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,587 Total Patients Enrolled

16 Trials studying Liver Cirrhosis

11,674 Patients Enrolled for Liver Cirrhosis

Marc T GoodmanPrincipal InvestigatorNorthwestern University

2 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Simvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02968810 — Phase 2

Liver Cirrhosis Research Study Groups: Group I (simvastatin), Group II (placebo)

Liver Cirrhosis Clinical Trial 2023: Simvastatin Highlights & Side Effects. Trial Name: NCT02968810 — Phase 2

Simvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02968810 — Phase 2

Frequently Asked Questions

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

Does this research project have room for more participants?

"At the moment, this particular trial is not looking for more patients. This study was first advertised on 6/21/2017 and was given an update on 10/21/2022. There are currently 485 other clinical trials involving cirrhosis of the liver that are actively recruiting participants and 37 different studies searching for patients that want to take Simvastatin."

Answered by AI

What makes this trial unique in comparison to others?

"Merck Sharp & Dohme LLC sponsored the first study of simvastatin in 2005, which involved 80 patients. Since this initial clinical trial, there have been 37 more studies conducted globally across 239 cities and 31 countries."

Answered by AI

What are the cholesterol-lowering capabilities of Simvastatin?

"Simvastatin is useful in the management of cholesterol, diabetes mellitus, and as a prophylactic measure against cardiovascular events."

Answered by AI

What have been the most common reported side-effects of Simvastatin?

"Simvastatin is a Phase 2 medication, meaning that while there is some evidence suggesting it is safe, there is no data yet indicating that it is effective."

Answered by AI

What is the recruitment goal for this clinical trial?

"Unfortunately, this particular trial is no longer recruiting patients. Although, if you're still interested in participating in clinical trials, there are currently 485 other trials for cirrhosis of the liver and 37 for Simvastatin that are actively looking for participants."

Answered by AI

Are there other examples of Simvastatin being used in a medical setting?

"The first study done on simvastatin was completed in 2005 at OHSU Hospital. In the 15 years since then, there have been a total of 492 studies pertaining to this medication - 37 of which are still ongoing. The majority of these active trials are based in Los Angeles, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis

2017. "Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02968810.

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