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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

Awards & highlights

LCN RESCU Trial 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.Check my eligibility

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).See study design

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.

LCN RESCU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in liver stiffness

Secondary outcome measures

All-cause mortality

Change in Child-Turcotte-Pugh score

Change in Enhanced Liver Fibrosis test

+15 more

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03074630

genital fungal infection

100%

80%

60%

40%

20%

Study treatment Arm

Adverse Events

LCN RESCU 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,314,336 Total Patients Enrolled

24 Trials studying Liver Cirrhosis

7,137 Patients Enrolled for Liver Cirrhosis

The Cleveland ClinicOTHER

1,030 Previous Clinical Trials

1,365,302 Total Patients Enrolled

8 Trials studying Liver Cirrhosis

1,376 Patients Enrolled for Liver Cirrhosis

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,447,003 Total Patients Enrolled

3 Trials studying Liver Cirrhosis

2,211 Patients Enrolled for Liver Cirrhosis

Media Library

Rosuvastatin (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT05832229 — Phase 2

Liver Cirrhosis Research Study Groups: Active, Placebo

Liver Cirrhosis Clinical Trial 2023: Rosuvastatin Highlights & Side Effects. Trial Name: NCT05832229 — Phase 2

Rosuvastatin (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05832229 — Phase 2

Frequently Asked Questions

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

Is there an age limit for enrolment in this research endeavor?

"This study is accepting participants aged between 18 and 75."

Answered by AI

Who meets the qualifications to take part in this medical trial?

"Patients in the age range of 18 to 75 who have been diagnosed with liver cirrhosis may be eligible for this study, which is looking to recruit 256 people."

Answered by AI

Has the FDA accorded its sanction to Active?

"Our team has rated the safety of Active a 2 due to its Phase 2 status, meaning that while there is some data verifying its security, no evidence exists yet to support efficacy."

Answered by AI

Is this clinical experiment going on in various locations throughout the state?

"This research is actively recruiting from 13 different sites across the country, including Los Angeles, San Francisco and Miami. It may be wise to select a location closest to you in order to minimise travel commitments if enrolling as a volunteer."

Answered by AI

Are there any open slots in this experiment that participants can fill?

"Unfortunately, the clinical trial is not presently recruiting patients according to information on clinicaltrials.gov. It was initially posted in July of 2023 and last edited in April of 2023. However, there are over seven hundred ninety-six other trials actively enrolling at this moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States

2023. "Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05832229.

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