Phase 2: testing Rosuvastatin for Cirrhosis
This is a neither you nor the study doctors know who gets the real treatment, phase 2 study to evaluate safety and how well it works of rosuvastatin in comparison to dummy treatment (placebo) after 2 years in patients with compensated cirrhosis.
Official registry: https://clinicaltrials.gov/study/NCT05832229 · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · enrollment listed as 260
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Rosuvastatin. The registry lists allocation as randomized. This is a neither you nor the study doctors know who gets the real treatment, phase 2 study to evaluate safety and how well it works of rosuvastatin in comparison to dummy treatment (placebo) after 2 years in patients with compensated cirrhosis.
They plan to enroll about 260 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study
Interventions: Rosuvastatin
Primary outcome (registry wording): Mean change in liver stiffness
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- Cirrhosis due to NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)
- Clinical diagnosis of cirrhosis as defined by investigator confirmation and the following:
- Two measures of VCTE: one at screening and one at the open-label dispense study visit, meeting the following criteria:
- The first measure must be ≥ 15.0 kPa
- 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 ≥ 15.0 kPa
- Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
Who the registry excludes
- Currently on a statin or any statin exposure within 24 weeks prior to consent
- Known indication for statin therapy, defined as:
- Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
- Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
- Fasting LDL-C ≥ 190 mg/dL
- Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening
- Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening
Public study contact (from the registry)
Crystal Santillanes, MS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
13 listed- University of California San Diego NAFLD Research Center — La Jolla, California (recruiting)
- Keck Medical Center of USC — Los Angeles, California (recruiting)
- LAC + USC Medical Center — Los Angeles, California (recruiting)
- UCSF/Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California (recruiting)
- UCSF Medical Center — San Francisco, California (recruiting)
- University of Miami Health System — Miami, Florida (recruiting)
- University of Michigan — Ann Arbor, Michigan (recruiting)
- Mayo Clinic — Rochester, Minnesota (recruiting)
- New York Presbyterian/Weill Cornell — New York, New York (recruiting)
- Columbia University Iriving School of Medicine — New York, New York (recruiting)
- Duke Liver Center — Durham, North Carolina (recruiting)
- Cleveland Clinic — Cleveland, Ohio (recruiting)
FAQ about this NCT record
Is NCT05832229 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05832229?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05832229?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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