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

Summary

This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.

Conditions

• Cirrhosis
• Cirrhosis, Liver
• Cirrhosis Early
• Cirrhosis Due to Hepatitis B
• Cirrhosis Advanced
• Cirrhosis Infectious
• Cirrhosis Alcoholic
• Cirrhosis Due to Hepatitis C

Interventions

DRUG

Rosuvastatin

Patients meeting all eligibility criteria will be assigned to a randomization arm prior to initiation of a 4-week lead-in phase of the study. All participants will undergo a 4-week, open-label active run-in phase to evaluate initial safety and adherence to rosuvastatin. During this active run-phase, all participants will receive target dose rosuvastatin-- 20 mg daily (10 mg daily for participants of East-Asian ancestry or on a protease inhibitor). After the active run-in phase, all participants will continue with their pre-assigned randomization (1:1) treatment of rosuvastatin 20 mg daily (10 mg daily for participants of East-Asian ancestry or on a protease inhibitor) or matching placebo.

Sponsors & Collaborators

• The Cleveland Clinic

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Duke University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• LAC+USC Medical Center

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• University of Southern California

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Abigail Smith, PhD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-07

Primary Completion

2029-08-31

Completion

2029-08-31

FDA Drug

Yes

Countries

• United States

Study Locations