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NCT03654053 · ClinicalTrials.gov registry record · Phase 3
Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis
A Phase 3 study of Cirrhosis, sponsored by VA Office of Research and Development.
- Active
- Registry status
- Phase 3
- Development phase
- 142
- Enrollment target
- 11
- Study locations
NCT03654053: Active Phase 3 study of Cirrhosis, sponsored by VA Office of Research and Development.
NCT03654053 is a Phase 3 study of Cirrhosis that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 142 participants, below the 90,406-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654053, a Phase 3 study of Cirrhosis, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 142 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase III, randomized, double-blind, placebo-controlled, multi-center study seeks to test whether simvastatin, a statin usually used to lower cholesterol to prevent heart problems and strokes, can lower the risk of hepatic decompensation (developing symptoms of cirrhosis) in U.S. Veterans who have compensated cirrhosis (the liver is scarred and damaged but there are no symptoms). The study will also explore how changes or differences in genes effect the safety and effectiveness of using statins and how the use of statins affects quality of life.
Primary Outcome
Occurrence of hepatic decompensation measured by first variceal hemorrhage, or development of ascites, or onset of hepatic encephalopathy, or hepatocellular carcinoma.
Conditions Studied
Interventions
- DRUG Simvastatin 40mg
- DRUG Placebo Oral Tablet
Study Locations (11)
New York
- Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY - Brooklyn
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia
- Philadelphia MultiService Center, Philadelphia, PA - Philadelphia
California
- San Francisco VA Medical Center, San Francisco, CA - San Francisco
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
Kentucky
- Robley Rex VA Medical Center, Louisville, KY - Louisville
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03654053 still lists
NCT03654053 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 90,406-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Simvastatin 40mg is the first listed.
NCT03654053 lists 11 locations in 9 states (New York, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT03654053 about?
NCT03654053 is a clinical study titled "Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis". This phase III, randomized, double-blind, placebo-controlled, multi-center study seeks to test whether simvastatin, a statin usually used to lower cholesterol to prevent heart problems and strokes, can lower the risk of hepatic decompensation (developing symptoms of cirrhosis) in U.S. Veterans who h...
What is the current status of trial NCT03654053?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 142 participants. The study started on 2020-10-02. Estimated completion is 2026-12-31.
What conditions does trial NCT03654053 study?
This clinical trial studies the following conditions: Cirrhosis.
What interventions are being tested in trial NCT03654053?
The interventions under investigation include: Simvastatin 40mg (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03654053?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03654053 being conducted?
This trial has 11 study locations across California, Connecticut, Kentucky, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03654053's enrollment target sits among peer trials
142 17th of 53 higher than 37 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
RECRUITING · Phase 3
-
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
COMPLETED · Phase 3
-
Gabapentin to Treat Itch in Patients With Liver Disease
COMPLETED · Phase 3
-
Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting
RECRUITING
-
LiverSleep: A Behavioral Sleep Intervention for Patients With Cirrhosis and Insomnia
RECRUITING · NA
-
Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
RECRUITING · Phase 2
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