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

Study acronym: LCN RESCU
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 256 to 260 Eligibility criteria expanded, about 57 words · Secondary endpoints: details revised at 2 of 18 entries · Study description shortened, about 24 words · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints: details revised at 2 of 18 entries
    • Study description shortened, about 24 words
    • Site details revised at 3 of 13 sites
  2. Site details revised at 1 of 13 sitesv11
  3. Primary and study completion dates: Nov 30, 2028 to Aug 31, 2029 Start date: Oct 11, 2023 to Dec 7, 2023v10 Show 1 more changeShow less
    • Start date: Oct 11, 2023 to Dec 7, 2023
  4. Start date: Dec 7, 2023 to Oct 11, 2023v9
  5. Primary and study completion dates: Nov 1, 2026 to Nov 30, 2028 Start date: Oct 11, 2023 to Dec 7, 2023v8 Show 1 more changeShow less
    • Start date: Oct 11, 2023 to Dec 7, 2023
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 40 wordsv7 See this version in full on ClinicalTrials.gov ↗
  2. Eligibility criteria shortened, about 15 words Secondary endpoints reordered · Site contacts updated at 2 of 13 sitesv6 Show 2 more changesShow less
    • Secondary endpoints reordered
    • Site contacts updated at 2 of 13 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 12 of 13 sitesv5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 1, 2023 to Oct 11, 2023 · Site details revised at 13 of 13 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 1, 2023 to Oct 11, 2023
    • Site details revised at 13 of 13 sites
  6. Primary completion date: Jul 31, 2028 to Nov 1, 2026 Start date: Jul 1, 2023 to Sep 1, 2023 · Completion date: Jul 31, 2029 to Nov 1, 2026v2 Show 2 more changesShow less
    • Start date: Jul 1, 2023 to Sep 1, 2023
    • Completion date: Jul 31, 2029 to Nov 1, 2026
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05832229
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: The Cleveland Clinic, Columbia University, Weill Medical College of Cornell University, Duke University, Mayo Clinic, University of Miami, University of Michigan, University of California, San Diego, University of California, San Francisco, LAC+USC Medical Center, Virginia Commonwealth University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Cancer Institute (NCI), University of Southern California
Conditions Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis Due to Hepatitis C
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov