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

30. april 2026 opdateret af: Naira Galal, Kafrelsheikh University

Dose Prediction for Statins and Anticoagulant Medications in Cirrhotic Patients Using Simcyp Program: Applications in Clinical Practice

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a prospective, open-label, pilot interventional clinical study conducted on adult cirrhotic patients with radiologically confirmed portal vein thrombosis. A total of twenty-one patients were enrolled from the outpatient clinics of the Hepatology, Gastroenterology, and Infectious Diseases Department at Kafrelsheikh University Hospital between March 2024 and March 2025.

Before initiation of anticoagulation therapy, all participants underwent comprehensive baseline clinical and laboratory assessments, including detailed medical history with emphasis on bleeding and thrombotic risk, physical examination, complete blood count, liver and renal function tests, and baseline coagulation profile. Eligible patients were classified according to Child-Pugh score into class A or B.

Patients with Child-Pugh class A (n = 10) received warfarin 3 mg once daily, while patients with Child-Pugh class B (n = 11) received warfarin 2 mg once daily. Initial dosing was guided by Simcyp® model predictions and the closest commercially available strengths. Enoxaparin was administered as bridging therapy at a therapeutic dose of 1 mg/kg twice daily until achievement of the target INR.

During the warfarin initiation phase, daily INR monitoring was performed, and dose adjustments were carried out using standardized clinical titration principles until a stable therapeutic INR (2.0-3.0) was achieved on two consecutive measurements. Patients were closely monitored throughout the follow-up period for treatment-related adverse events, with particular emphasis on bleeding complications. Bleeding events were systematically assessed and classified as minor or major, in addition to monitoring for any thromboembolic events.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Fase 4

Kontakter og lokationer

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Studiesteder

  • Egypten
      • Cairo, Egypten
        • Kafrelsheikh University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Child-Pugh Class A (n = 10)
Adult cirrhotic patients with portal vein thrombosis received 3 mg warfarin oral once daily (Marevan® 3 mg, GSK, Egypt) Other Intervention (Bridging Therapy): Enoxaparin (1 mg/kg) subcutaneously twice daily until achievement of a stable therapeutic INR (2.0-3.0).
Medicin: Warfarin 3 mg
Warfarin is a vitamin K antagonist approved for the treatment of thromboembolic disorders and was used in this study for anticoagulation in cirrhotic patients with portal vein thrombosis.
Eksperimentel: Child-Pugh Class B (n = 11)

Adult cirrhotic patients with portal vein thrombosis received 2 mg warfarin oral once daily (2 tablets of Marevan® 1 mg, GSK, Egypt).

Other Intervention (Bridging Therapy): Enoxaparin (1 mg/kg) subcutaneously twice daily until achievement of a stable therapeutic INR (2.0-3.0).
Medicin: Warfarin 2 mg
Warfarin is a vitamin K antagonist approved for the treatment of thromboembolic disorders and was used in this study for anticoagulation in cirrhotic patients with portal vein thrombosis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Achieve Therapeutic INR
Tidsramme: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
The number of days from initiation of warfarin therapy until an INR value within the therapeutic range (≥ 2.0) was documented.
From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average Warfarin Dose During Initiation Phase
Tidsramme: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
The mean daily warfarin dose required to achieve therapeutic anticoagulation during the initiation phase.
From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Proportion of Patients Achieving Therapeutic INR Within 3-5 Days
Tidsramme: Within 3-5 days after warfarin initiation
The percentage of patients who achieved therapeutic INR (≥ 2.0) within 3 to 5 days after initiation of warfarin therapy.
Within 3-5 days after warfarin initiation
Follow-up Duration During Warfarin Initiation Phase
Tidsramme: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
The duration of patient follow-up during the warfarin initiation phase, measured in days.
From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Incidence of Over-Anticoagulation
Tidsramme: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
The occurrence of excessive anticoagulation, defined as an international normalized ratio (INR) value greater than 4 during the initiation phase.
From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Incidence of Bleeding Events
Tidsramme: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
The occurrence of bleeding complications during the study follow-up period, classified as minor or major according to standard clinical criteria.
From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Incidence of Thromboembolic Events
Tidsramme: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
The occurrence of any new thromboembolic events during the follow-up period after initiation of warfarin therapy.
From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)

Samarbejdspartnere og efterforskere

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Sponsor

Kafrelsheikh University

Efterforskere

  • Studieleder: Noha Mahmoud El-khodary, PhD, Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University
  • Ledende efterforsker: Naira Galal, BSc Pharm, Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. marts 2024

Primær færdiggørelse (Faktiske)

15. marts 2025

Studieafslutning (Faktiske)

15. marts 2025

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KFSIRB200-127-B
  • KFSIRB200-127 (Registry Identifier: Kafrelsheikh University IRB)

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