Atorvastatin 20mg for Liver Fibroses

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Texas Southwestern Medical Center, Dallas, TX
Liver Fibroses+3 More
Atorvastatin 20mg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called atorvastatin can prevent liver cancer in people with liver fibrosis.

See full description

Eligible Conditions

  • Liver Fibroses
  • Cirrhosis of the Liver

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Atorvastatin 20mg will improve 3 primary outcomes and 2 secondary outcomes in patients with Liver Fibroses. Measurement will happen over the course of 48 weeks.

48 weeks
Complete adverse event profile
Reduced magnitude of high-risk PLS after treatment vs before treatment
Reduced magnitude of high-risk PLsec after treatment vs before treatment
Reduced prevalence of high-risk PLS
Reduced prevalence of high-risk PLsec

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Atorvastatin 20mg
Myalgia
2%
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01660191) in the Atorvastatin 20mg ARM group. Side effects include: Myalgia with 2%.

Trial Design

2 Treatment Groups

Group A: Atorvastatin 20 mg
1 of 2
Group B: Placebo to Match (PTM)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Atorvastatin 20mg is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Group A: Atorvastatin 20 mg
Drug
Atorvastatin 20mg will be administered daily via oral route for 48 consecutive weeks on an outpatient basis.
Group B: Placebo to Match (PTM)
Drug
PTM will be administered daily via oral route for 48 consecutive weeks on an outpatient basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 48 weeks for reporting.

Closest Location

University of Texas Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text states that the individual has advanced fibrosis (METAVIR 3-4) during the 12-week screening period show original
If you are a woman who could potentially have children and you are heterosexual, you must agree to use a method of contraception specified by the protocol. show original
This person is willing and able to provide consent that is informed. show original
A person who is male or female and over the age of 18 at the time they consent may choose to have sexual intercourse. show original
Liver imaging within 6 months of Day 1 is required in cirrhotic subjects only, to exclude HCC
This person is willing and able to undergo a liver biopsy, which is a standard medical procedure. show original
The subject must be able to comply with the instructions for taking the study drug and be able to complete the study schedule of assessments. show original

Patient Q&A Section

What causes fibrosis?

"Because fibrosis progresses even with the absence of external stimuli, we suggest that the process of fibrosis should be considered a pathological response to chronic physiological alterations." - Anonymous Online Contributor

Unverified Answer

Can fibrosis be cured?

"Fibrosis can be avoided by quitting smoking and stopping drinking alcohol, avoiding excessive prolonged heavy weight lifting and heavy lifting of any kind, and managing chronic pain and avoiding/eliminating any stressful or irritating events with prolonged exposure to them during an entire year. A high-intensity interval training is particularly useful in preventing excessive physical fatigue during the healing process. The ultimate goal of all rehabilitation is, however, to remove the root causes of the disease so these risk factors can be eliminated." - Anonymous Online Contributor

Unverified Answer

What are the signs of fibrosis?

"The signs of fibroblast activation include increased production of extracellular matrix to maintain tissue damage, and may include the appearance of histologic scars. Signs of tissue destruction include the appearance of scar tissue (desmoid-type fibroma in the case of desmoid tumours), and scarring around the tumor." - Anonymous Online Contributor

Unverified Answer

What is fibrosis?

"Fibrosis involves the progressive replacement of tissue by scar tissue and is a characteristic feature of chronic liver diseases (such as cirrhosis) and cancer. The origin of the term fibrosis comes from the Greek word "stin" meaning 'a band' or 'tendon' and the verb"" - Anonymous Online Contributor

Unverified Answer

How many people get fibrosis a year in the United States?

"Over 80% will not develop fibrosis in their lifespan; however, an alarming proportion of men will need to take some form of antifibrotic therapy over the lifetime. Fibrosis has a significant impact on patients' health-related quality of life and on their willingness to continue with conventional therapy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fibrosis?

"This is the most comprehensive overview of treatments for fibrosis of the liver with a wide range of treatments. Current treatments are generally limited to alleviating the symptoms arising from liver disease rather than altering the underlying cause or pathology." - Anonymous Online Contributor

Unverified Answer

How does atorvastatin 20mg work?

"While a number of studies have shown that atorvastatin can reduce the amount of plaques in human artery wall, the amount of this reduction is quite variable and does not translate into a reduction in the size of the plagues. Further research is needed to understand the optimal effects of atorvastatin on the vascular wall in order to better establish the potential use of this drug in the prevention of cardiovascular disease." - Anonymous Online Contributor

Unverified Answer

How serious can fibrosis be?

"Fibrosis is not only a debilitating disease state; it is also a significant prognostic factor for disease-related progression or the need for liver transplantation. The incidence, prevalence, severity, and prognostic significance of fibrosis are widely variable." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets fibrosis?

"About half of my patients get fibrosis at a relatively young age (<50 years); the remainder have it at a typical patient age of 75-80 years. This difference is significant since fibrosis carries a 5-year risk of developing pancreatico-islet autoimmunity, pancreatitis, or diabetes. There may be a benefit to screening for high-risk fibrosis patients earlier than 5 years of age." - Anonymous Online Contributor

Unverified Answer

What is the latest research for fibrosis?

"Fibrosis is the process by which scar tissue builds up in different organs by a process that is not yet understood. Researchers have been actively investigating [the factors affecting the process of scarring] to prevent or slow down fibrosis, which can cause organ dysfunction and eventually death." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating fibrosis?

"There have not. Research has progressed the knowledge of fibrosis. The treatment of fibrosis will hopefully continue to progress so the patients can get more options for treatment. (author, N." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in atorvastatin 20mg for therapeutic use?

"Atorvastatin 20mg given once daily was well tolerated, improved insulin sensitivity and other lipid parameters and reduced atherosclerotic coronary atherosclerosis. Future clinical studies are planned." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Liver Fibroses by sharing your contact details with the study coordinator.