CompletedPhase 4

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

Egypt22 participantsStarted 2024-03-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients aged ≥ 18 years * Confirmed diagnosis of liver cirrhosis (clinical, laboratory, or imaging evidence) * Evidence of portal hypertension (clinical findings and/or Doppler ultrasound measurements) * No previous history of variceal bleeding * Child-Pugh class A or B Exclusion Criteria: * Active hepatocellular carcinoma * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) * Baseline creatine kinase (CK) \> 3 × upper limit of normal * Known hypersensitivity to simvastatin * Current therapy with strong CYP3A4 inhibitors * Any active malignancy in the last 2 years * Pregnancy or lactation

What they're measuring

Change in Portal Vein Diameter (mm)

Timeframe: 3 months

Change in Portal Vein Velocity (cm/s)

Timeframe: 3 months

Change in Hepatic Artery Resistance Index (HARI)

Timeframe: 3 months

Change in Congestion Index (CI) (cm/ [cm/s2])

Timeframe: 3 months

Change in Modified Vascular Liver Index (MVLI) (cm/s)

Timeframe: 3 months

Change in Platelet Count (×10⁹/L)

Timeframe: 3 months

Trial details

NCT IDNCT07459972

SponsorKafrelsheikh University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-15

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