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

Part of paid clinical trials in La Jolla, California.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT05832229
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cirrhosis
  • Cirrhosis Advanced
  • Cirrhosis Alcoholic
  • Cirrhosis Due to Hepatitis B
  • Cirrhosis Due to Hepatitis C
  • Cirrhosis Early
  • Cirrhosis Infectious
  • Cirrhosis, Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rosuvastatin — DRUG
    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 or on a protease inhibitor). 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 on a protease inhibitor) or matching placebo.

Study Details

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.

Key Dates

Start date
Dec 7, 2023
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    Open-label lead-in period of 4 weeks on 20 mg (10 mg for participants of East ancestry or on a protease inhibitor) rosuvastatin by mouth once daily, followed by a period of 96 weeks rosuvastatin 20 mg daily (10 mg daily for participants of East-Asian ancestry or on a protease inhibitor).
  • Placebo Comparator: Placebo
    Open-label lead-in period of 4 weeks on 20 mg (10 mg for participants of East ancestry or on a protease inhibitor) rosuvastatin by mouth once daily, followed by a period of 96 weeks placebo.

Primary Outcome Measure

Mean change in liver stiffness [ Time Frame: 96 weeks ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of California San Diego NAFLD Research CenterLa JollaCalifornia92035
Rohit Loomba
[email protected]
Keck Medical Center of USCLos AngelesCalifornia90033
Norah Terrault
[email protected]
LAC + USC Medical CenterLos AngelesCalifornia90033
Norah Terrault
[email protected]
UCSF Medical CenterSan FranciscoCalifornia94143
Bilal Hameed
[email protected]
UCSF/Zuckerberg San Francisco General Hospital and Trauma CenterSan FranciscoCalifornia94110
Mandana Khalili
[email protected]
University of Miami Health SystemMiamiFlorida33122
David Goldberg
[email protected]
University of MichiganAnn ArborMichigan48109
Elliot Tapper
[email protected]
Mayo ClinicRochesterMinnesota55901
Doug A. Simonetto, MD
[email protected]
(507) 284-2511
Columbia University Iriving School of MedicineNew YorkNew York10031
Elizabeth Verna
[email protected]
New York Presbyterian/Weill CornellNew YorkNew York10021
Robert Brown
[email protected]
Duke Liver CenterDurhamNorth Carolina27710
Cynthia Ann Moylan, MD, MHS, MS
[email protected]
919-681-4044
Mariko Kopping
[email protected]
Cleveland ClinicClevelandOhio44192-
Virginia Commonwealth UniversityRichmondVirginia23298

Find similar trials in La Jolla, CA

By research site
University of California San Diego NAFLD Research Center· La Jolla, CAKeck Medical Center of USC· Los Angeles, CALAC + USC Medical Center· Los Angeles, CAUCSF Medical Center· San Francisco, CAUCSF/Zuckerberg San Francisco General Hospital and Trauma Center· San Francisco, CAUniversity of Miami Health System· Miami, FL

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