Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

• Status: Not yet recruiting
• Trial end date: 2028-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Raymond Chung
• Collaborator: University of Texas Southwestern Medical Center
• Treatments: Atorvastatin

Criteria

Inclusion Criteria:

• Willing and able to provide informed consent

• Male or female age > 18 years at time of consent

• Liver biopsy showing advanced fibrosis (METAVIR 3-4) during 12-week screening period (may be from archived liver biopsy within 48-weeks of screening)

• Liver imaging within 6 months of Day 1 is required in cirrhotic subjects only, to exclude HCC

• Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

• Willing and able to undergo protocol liver biopsy

• Subject must be able to comply with dosing instructions for study drug administration and able to complete study schedule of assessments.

Exclusion Criteria:

• Current or prior history of any clinically significant illness or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol

• Known positivity for HIV infection

• Active, untreated HCV infection (Patients with prior history of HCV who achieved sustained virologic response (SVR) >12 from Day 1 may be included in the study)

• Uncontrolled chronic HBV (Patients with well-controlled disease with >12 months of stable medication use [or no medication use, in those persons for whom anti-HBV therapy is not indicated])

• Clinical hepatic decompensation (defined as Child's Pugh class B or C cirrhosis)

• History of biliary diversion

• Solid organ transplant

• Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible

• Pregnant or Nursing Females (a negative serum pregnancy test is required at screening for WOCBP)

• Life-threatening SAE during the screening period

• ALT > 10 x ULN

• AST > 10 x ULN

• Hemoglobin < 8.5 g/dl

• Serum creatinine > 2.0 mg/dL

• CK > 3x ULN.

• Females who may wish to become pregnant and/or plan to undergo egg harvesting during the study and up to 30 days of the last dose of study drug.

• WOCBP must abstain from breastfeeding and be willing to use effective birth control during through the week 4 post treatment follow-up visit.

• Clinically relevant alcohol or drug abuse within 12 months of screening

• Use of any prohibited concomitant medications

• Use of a statin medication within 90 days of Day 1 visit (Subjects who are on a current statin at time of consent must be willing to undergo a 90-day washout period prior to randomization)

• Known hypersensitivity to Atorvastatin

• Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through the week 4 post treatment follow-up visit.