Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Raymond Chung
Study ID
NCT05028829
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cirrhosis
  • Liver Fibroses

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atorvastatin 20mg — DRUG
    Oral administration of atorvastatin 20 mg
  • Placebo — DRUG
    Oral administration of placebo

Study Details

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.

Key Dates

Start date
May 10, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Mar 1, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group A: Atorvastatin 20 mg
    Atorvastatin 20mg will be administered daily via oral route for 48 consecutive weeks on an outpatient basis.
  • Placebo Comparator: Group B: Placebo to Match (PTM)
    PTM will be administered daily via oral route for 48 consecutive weeks on an outpatient basis.

Primary Outcome Measure

Reduced magnitude of high-risk PLSec after treatment vs before treatment [ Time Frame: 48 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Raymond Chung, MD
[email protected]
Raymond Chung, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Yujin Hoshida, MD
[email protected]
Yujin Hoshida, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MAUniversity of Texas Southwestern Medical Center· Dallas, TX

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