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Liver CirrhosisPhase 4NCT07571460

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

A Phase 4 study testing Warfarin 3 mg and Warfarin 2 mg in people with Liver Cirrhosis and Portal Vein Thrombosis, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis, Portal Vein Thrombosis
What is being tested?
Warfarin 3 mg and Warfarin 2 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteEgypt
Study dates
15 Mar 2024to 15 Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kafrelsheikh University

    Cairo

Other trials in Egypt

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Warfarin 3 mg, Warfarin 2 mg
Keywords
Liver cirrhosis, Portal vein thrombosis, Warfarin
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Warfarin 3 mgDrug

    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.

  • Warfarin 2 mgDrug

    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.

Study groups in NCT07571460
Study groupRoleWhat they receive
Child-Pugh Class A (n = 10)ExperimentalAdult 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).
Receives: Drug: Warfarin 3 mg
Child-Pugh Class B (n = 11)ExperimentalAdult 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).
Receives: Drug: Warfarin 2 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Average Warfarin Dose During Initiation Phase

    The mean daily warfarin dose required to achieve therapeutic anticoagulation during the initiation phase.

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

  2. Proportion of Patients Achieving Therapeutic INR Within 3-5 Days

    The percentage of patients who achieved therapeutic INR (≥ 2.0) within 3 to 5 days after initiation of warfarin therapy.

    Measured: Within 3-5 days after warfarin initiation

  3. Follow-up Duration During Warfarin Initiation Phase

    The duration of patient follow-up during the warfarin initiation phase, measured in days.

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

  4. Incidence of Over-Anticoagulation

    The occurrence of excessive anticoagulation, defined as an international normalized ratio (INR) value greater than 4 during the initiation phase.

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

  5. Incidence of Bleeding Events

    The occurrence of bleeding complications during the study follow-up period, classified as minor or major according to standard clinical criteria.

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

  6. Incidence of Thromboembolic Events

    The occurrence of any new thromboembolic events during the follow-up period after initiation of warfarin therapy.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start15 Mar 2024
  3. Primary completion15 Mar 2025
  4. Study completion15 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07571460
Sponsor's protocol ID
KFSIRB200-127-B
Other IDs
KFSIRB200-127
Status last verified
Apr 2026
First submitted
23 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36858157

  • 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.

    PubMed 39708000

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Warfarin 3 mg and Warfarin 2 mg in people with Liver Cirrhosis and Portal Vein Thrombosis, run by Kafrelsheikh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Achieve Therapeutic INR (time frame: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07571460, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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