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

30. april 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

21

Fase

  • Fase 4

Kontakter og plasseringer

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Studiesteder

  • Egypt
      • Cairo, Egypt
        • Kafrelsheikh University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: 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.
Eksperimentell: 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).
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

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Sponsor

Kafrelsheikh University

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. mars 2024

Primær fullføring (Faktiske)

15. mars 2025

Studiet fullført (Faktiske)

15. mars 2025

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KFSIRB200-127-B
  • KFSIRB200-127 (Registeridentifikator: Kafrelsheikh University IRB)

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UBESLUTTE

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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