The ex-vivo potency of Edoxaban in patients with cirrhosis

The ex-vivo potency of Edoxaban in patients with cirrhosis - POET study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45987

Enrollment

Registered

2016-07-20

Start date

2016-12-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

end stage liverdisease Fibrosis

Interventions

Since HIV-positivity is an exclusion criterium each subject will be tested prior to enrolment. Overview of planned interventions (this will be performed when the subjects are admitted for their sc

2.5 hrs Two blood withdrawals (before and after the first gift of edoxaban) Physical examination First gift of edoxaban * Control 2 at the participants* home on day 3

+/- 20 min Physical examination Assessment of vital parameters One blood withdrawal * Control 3 at the participants* home on day 7

+/- 20 min Physical examination Assessment of vital parameters One blood withdrawal When possible we will combine the first control together with an outpatient clinic appointment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age over 18 yrs - Child Pugh A or B cirrhosis - Informed consent

Exclusion criteria

Exclusion criteria: * Malignancies * Renal failure requiring intervention with drugs or dialysis * Weight under 60 kg * Active infection * Use of anticoagulant drugs in the past 10 days * Use of cyclosporine, dronedarone, erythromycin, or ketoconazole * Documentation of inherited bleeding disorders * History of hepatic disease (in the controls) * History of thrombotic disease * Recent viral infection (less than two weeks prior to participation) * Recent (variceal) bleeding or known present varices grade 2-3/3 * Pregnancy * HIV-infection

Design outcomes

Primary

Measure	Time frame
This study will measure the percentual difference in thrombin generation capacity of plasma taken at baseline versus plasma taken at steady state in patients with cirrhosis and healthy controls. The main endpoint of the study is the difference between the anticoagulant potency (as expressed by percentual decrease in thrombin generation) of edoxaban in patients compared to controls.	—

Secondary

Measure	Time frame
This study will also look into the occurence of adverse events and the plasma levels of Edoxaban compared to an anti-Xa assay (calibrated for Edoxaban). Adverse events will be divided into several categories; death, major bleeding, moderate bleeding and mild bleeding events. Major bleeding events are defined as a bleeding at a critical site, a bleeding leading to a loss of 2g/dl of hemoglobin or requiring transfusion of more than two units of blood. Moderate bleeding events do not meet the criteria for major bleeding events but do require medical intervention of transfusion. Mild events do not require intervention or discontinuation of the study drugs. Other end-points: Prothrombin time, activated partial prothrombin time, D-dimer, factor I and II.	—

Measure

Time frame

This study will also look into the occurence of adverse events and the plasma levels of Edoxaban compared to an anti-Xa assay (calibrated for Edoxaban). Adverse events will be divided into several categories; death, major bleeding, moderate bleeding and mild bleeding events. Major bleeding events are defined as a bleeding at a critical site, a bleeding leading to a loss of 2g/dl of hemoglobin or requiring transfusion of more than two units of blood. Moderate bleeding events do not meet the criteria for major bleeding events but do require medical intervention of transfusion. Mild events do not require intervention or discontinuation of the study drugs. Other end-points: Prothrombin time, activated partial prothrombin time, D-dimer, factor I and II.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)