Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cirrhosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To evaluate the effect of a simvastatin intervention versus placebo on the change in serum AFP-L3% from baseline to 6 months following treatment initiation in patients with liver cirrhosis who have a current model for end-stage liver disease (MELD) =< 20. SECONDARY OBJECTIVES: ...
PRIMARY OBJECTIVE: I. To evaluate the effect of a simvastatin intervention versus placebo on the change in serum AFP-L3% from baseline to 6 months following treatment initiation in patients with liver cirrhosis who have a current model for end-stage liver disease (MELD) =< 20. SECONDARY OBJECTIVES: I. To evaluate the effect of a simvastatin intervention versus placebo at 6 months on the change in: Ia. Serum AFP. Ib. Serum IL-6. Ic. Serum bile acid levels. Id. Liver stiffness. Ie. Fibrosis 4 index (FIB-4) score. If. MELD score. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive simvastatin orally (PO) once daily (QD). GROUP II: Patients receive placebo PO QD. In both groups, treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30, 60, and 90 days.
Tracking Information
- NCT #
- NCT02968810
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marc T Goodman Northwestern University
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