Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (NCT05832229) | Clinical Trial Compass
RecruitingPhase 2
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
United States256 participantsStarted 2023-12-07
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Age 18-75 years
ā. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
ā. Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
ā. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
ā. At least 2 of the following:
ā. Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
ā. The first measure must be ā„ 15 kilopascal.
ā. The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
Exclusion criteria
ā. Currently on a statin or any statin exposure within 24 weeks prior to consent.
ā. Known indication for statin therapy, defined as:
ā. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
ā. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
What they're measuring
1
Mean change in liver stiffness
Timeframe: 96 weeks
Trial details
NCT IDNCT05832229
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)