Actively Recruiting
Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk
Led by Raymond Chung · Updated on 2025-09-23
60
Participants Needed
2
Research Sites
407 weeks
Total Duration
On this page
Sponsors
R
Raymond Chung
Lead Sponsor
U
University of Texas Southwestern Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Male or female age > 18 years at time of consent
- Diagnosed advanced liver fibrosis or cirrhosis confirmed by liver biopsy, Fibroscan, MR elastography, imaging, or clinical evaluation
- High risk for hepatocellular carcinoma at screening according to the FIB-4 index
- PLSec score ≥ 3 measured in screening blood samples
- Liver imaging within 6 months before Day 1 for cirrhotic subjects to exclude liver cancer
- Female subjects of childbearing potential must agree to use specified contraception
- Willing and able to undergo blood sampling per protocol
- Able to comply with dosing and complete study assessments
You will not qualify if you...
- Diagnosis of alpha-1-antitrypsin deficiency, Wilson disease, hemochromatosis, iron overload, or prior known/suspected drug-induced liver injury
- Patients with PBC, PSC, AIH, or stable hemochromatosis excluded unless overlapping with steatotic liver disease
- Clinically significant illness or major medical disorder interfering with treatment or protocol compliance
- Known HIV infection
- Active untreated hepatitis C virus infection (prior treated HCV with sustained response >12 months allowed)
- Uncontrolled chronic hepatitis B virus infection (stable controlled allowed)
- Clinical hepatic decompensation beyond Child's Pugh class B7 (class B7 may be included)
- History of biliary diversion
- Solid organ transplant
- Malignancy within 5 years before screening except certain cured cancers
- Pregnant or nursing females (negative pregnancy test required at screening)
- Life threatening serious adverse event during screening
- Abnormal lab parameters: ALT > 10x ULN, AST > 10x ULN, hemoglobin < 8.5 g/dl, serum creatinine > 2.0 mg/dL, CK > 3x ULN
- Females planning pregnancy or egg harvesting during study and 30 days after last dose
- Women of childbearing potential must abstain from breastfeeding and use birth control through week 4 post treatment
- Clinically relevant alcohol or drug abuse within 12 months
- Use of prohibited medications as per protocol
- Use of statin medication within 90 days before Day 1 (90-day washout required if currently on statin)
- Known hypersensitivity to atorvastatin
- Participation in another investigational new drug trial within 30 days prior to randomization through week 4 post treatment follow-up visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
R
Raymond Chung, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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