Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study
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.
• Age 18-75 years
• Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
• Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
‣ At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
⁃ At least 2 of the following:
• i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\>2.67 or platelets \<150/mL within 6 months prior to consent or during Screening
• Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
‣ The first measure must be ≥ 15 kilopascal.
⁃ The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
⁃ The mean of two measurements must be ≥ 15 kilopascal.
⁃ Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
• Compensated defined by:
‣ Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.
⁃ If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.
⁃ Child-Pugh score \<8
• Provision of written informed consent.