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Statins
Rosuvastatin for Liver Cirrhosis (LCN RESCU Trial)
Phase 2
Recruiting
Led By Jody Ciolino
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 96 weeks
Summary
This trial tests if a drug can safely and effectively treat cirrhosis.
Who is the study for?
Adults aged 18-75 with compensated cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, chronic viral hepatitis, or cryptogenic causes. Participants must have a clinical diagnosis of cirrhosis confirmed by biopsy or other criteria and cannot be on statins or have conditions like uncontrolled diabetes, recent serious cardiovascular events, active substance abuse, certain infections or cancers.
What is being tested?
The trial is testing the safety and effectiveness of rosuvastatin versus a placebo in patients with compensated cirrhosis over two years. It's a phase 2 study where neither the participants nor the researchers know who receives the actual medication (double-blind).
What are the potential side effects?
Potential side effects of rosuvastatin may include muscle pain or weakness (myositis), increased risk for liver injury, digestive issues such as constipation or nausea, headache, feeling dizzy or weak.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in liver stiffness
Secondary study objectives
All-cause mortality
Change in Child-Turcotte-Pugh score
Change in Enhanced Liver Fibrosis test
+15 moreSide effects data
From 2018 Phase 4 trial • 12 Patients • NCT030746308%
genital fungal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adverse Events
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Open-label lead-in period of 4 weeks on 20 mg (10 mg for participants of East ancestry) rosuvastatin by mouth once daily, followed by a period of 96 weeks rosuvastatin 20 mg daily (10 mg daily for participants of East-Asian ancestry).
Group II: PlaceboPlacebo Group1 Intervention
Open-label lead-in period of 4 weeks on 20 mg (10 mg for participants of East ancestry) rosuvastatin by mouth once daily, followed by a period of 96 weeks placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
2019
Completed Phase 4
~3150
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
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4,337,197 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cirrhosis caused by fatty liver, alcohol, viral hepatitis, or unknown reasons.I have chronic hepatitis B or C that has not been treated.I experience significant muscle pain or tenderness.My liver disease is stable without severe symptoms.I have not had a heart attack, unstable chest pain, mini-stroke, or stroke in the last 6 months.I am between 18 and 75 years old.I have a history of liver cancer or related liver conditions.My kidney function is not normal.I have a blood clot in the liver or portal vein.I am currently using or have recently used statins.I am taking medication that may increase my risk for certain side effects.I have a serious health condition that affects my life expectancy.I might have trouble attending all study visits.My cirrhosis has been confirmed by a doctor using tests or imaging.My liver is currently failing or has recently failed.I am not taking any medications that could affect my liver or interfere with test results.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.