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

NCT07571460 | Completed Phase 4 DMC

• 2 other identifiers: KFSIRB200-127-BKFSIRB200-127
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cirrhosis; Portal Vein Thrombosis

Keywords

Liver cirrhosis; Portal vein thrombosis; Warfarin

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Therapeutic INR

  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)

Secondary Outcomes (6)

• Average Warfarin Dose During 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

  Within 3-5 days after warfarin initiation

• Follow-up Duration During Warfarin Initiation Phase

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

• Incidence of Over-Anticoagulation

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

• Incidence of Bleeding Events

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

Study Arms (2)

Child-Pugh Class A (n = 10)

EXPERIMENTAL

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).

Drug: Warfarin 3 mg

Child-Pugh Class B (n = 11)

EXPERIMENTAL

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).

Drug: Warfarin 2 mg

Interventions

Warfarin 3 mg DRUG

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.

Child-Pugh Class A (n = 10)

Warfarin 2 mg DRUG

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.

Child-Pugh Class B (n = 11)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Cairo, Egypt

Location

Related Publications (2)

• Guerrero A, Campo LD, Piscaglia F, Scheiner B, Han G, Violi F, Ferreira CN, Tellez L, Reiberger T, Basili S, Zamora J, Albillos A; Baveno Cooperation: an EASL consortium. Anticoagulation improves survival in patients with cirrhosis and portal vein thrombosis: The IMPORTAL competing-risk meta-analysis. J Hepatol. 2023 Jul;79(1):69-78. doi: 10.1016/j.jhep.2023.02.023. Epub 2023 Feb 28.

  PMID: 36858157 BACKGROUND

• Davis JPE, Lim JK, Francis FF, Ahn J. AGA Clinical Practice Update on Management of Portal Vein Thrombosis in Patients With Cirrhosis: Expert Review. Gastroenterology. 2025 Feb;168(2):396-404.e1. doi: 10.1053/j.gastro.2024.10.038. Epub 2024 Dec 20.

  PMID: 39708000 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Naira Galal, BSc Pharm

  Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

• Noha Mahmoud El-khodary, PhD

  Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 6, 2026
• Study Start: March 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

EG (1)