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

Cirrhosis Clinical Trial

Official title: Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial, of 20mg (or 10mg for participants of East Asian ancestry) of rosuvastatin by mouth, once daily. Participants will be randomized (1:1) to either once daily placebo or once daily 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). 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 matching placebo.

The total duration of the study will be 96 weeks in the assigned treatment arm plus the 4-week lead-in period. The primary outcome will be the mean change in liver stiffness from the baseline measurement to the end of study liver stiffness, as measured by ultrasound-based vibration-controlled transient elastography (VCTE).

There are 10 participating clinical centers, and we anticipate a total of 256 patients will be recruited for the initial lead-in as we estimate 20% of participants may dropout after the lead-in (256 x 0.8 = 204 for randomization into the study drug treatment phase). ;

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Cirrhosis
• Cirrhosis Due to Hepatitis B
• Cirrhosis Due to Hepatitis C
• Cirrhosis, Liver
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic
• Liver Cirrhosis, Biliary

• NCT number: NCT05832229
• Study type: Interventional
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: Crystal Santillanes
• Phone: 312-503-5536
• Email: lcn@northwestern.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2023
• Completion date: November 1, 2026