Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRaymond Chung
About this trial
Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.
Eligibility criteria
Qualifiers
Willing and able to provide informed consent
Male or female age > 18 years at time of consent
Liver biopsy demonstrating advanced fibrosis or cirrhosis (METAVIR 3-4)
Fibroscan or MR elastography consistent with advanced fibrosis or cirrhosis
Disqualifiers
alpha-1-antitrypsin (A1AT) deficiency, Wilson disease, hemochromatosis, iron overload, prior known or suspected drug-induced liver injury (DILI)
Patients with PBC, PSC, AIH, or stable hemochromatosis may be included if their liver disease etiology overlaps with that of steatotic liver disease (SLD)
Known positivity for HIV infection
Active, untreated HCV infection
Trial design
Treatments tested in this trial
- Atorvastatin 20mg
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Raymond Chung
Lead sponsor
Massachusetts General Hospital
Sponsor institution
University of Texas Southwestern Medical Center
Collaborator
Source ClinicalTrials.gov