CompletedPhase 4

Clinical Application of Simcyp-Guided Warfarin Initiation Doses in Cirrhotic Patients With Portal Vein Thrombosis

Egypt21 participantsStarted 2024-03-15

Plain-language summary

This was a prospective, open-label, pilot interventional clinical study conducted on Egyptian patients with liver cirrhosis complicated by portal vein thrombosis (PVT) who were indicated for anticoagulation therapy. The study aimed to evaluate the clinical applicability of Simcyp®-guided warfarin initiation doses according to Child-Pugh class, focusing on the time required to achieve a therapeutic INR and the safety of anticoagulation during the initiation phase.

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: * Age ≥ 18 years * Diagnosed liver cirrhosis (Child-Pugh A or B) * Radiologically confirmed portal venous thrombosis * No prior exposure to warfarin (for initial dose simulation) * No pervious history of variceal bleeding Exclusion Criteria: * Child-Pugh C cirrhosis * Platelets \< 50,000/mm³ * Severe renal impairment (eGFR \< 30 mL/min) * Use of strong CYP2C9/CYP3A4 inhibitors or inducers * Pregnancy or breastfeeding * Active malignancy, especially hepatocellular carcinoma

What they're measuring

Time to Achieve Therapeutic INR

Timeframe: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)

Trial details

NCT IDNCT07571460

SponsorKafrelsheikh University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-15

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