Clinical Trial

Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis

Completed Phase 4
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Summary
This prospective open-label parallel pilot clinical study evaluated the efficacy and safety of physiologically based pharmacokinetic (PBPK)-guided simvastatin dosing in Child-Pugh A and B cirrhotic patients with portal hypertension over a 3-month period. Twenty-two patients were enrolled following screening, and portal hemodynamic, laboratory, and safety parameters were assessed.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-04.
Trial Details
NCT Number NCT07459972
Lead Sponsor Kafrelsheikh University
Conditions Liver Cirrhosis, Portal Hypertension Related to Cirrhosis
Enrollment 22 participants
Start Date 2024-03-15
Primary Completion 2025-03-15 (estimated)
Study Completion 2025-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-11