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HMG-CoA Reductase Inhibitor

Simvastatin for Preventing Liver Cancer in Patients With Cirrhosis

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 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%
0%
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
~1890
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Simvastatin
2012
Completed Phase 4
~1270

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,633 Previous Clinical Trials
40,928,668 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
~10 spots leftby Apr 2025