The treatment of venous thromboembolism with edoxaban in patients with cirrhosis, a pharmacokinetic study.

Phase 4

Recruiting

• Conditions: deep vein thrombosis; Venous thrombosis; 10019654; 10014523

• Registration Number: NL-OMON49068
• Lead Sponsor: Tergooi ziekenhuizen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

- Age >18 years
- Child Pugh A or B cirrhosis as assessed by treating gastroenterologist
- A diagnosis of venous thromboembolism (deep vein thrombosis, pulmonary
embolism, portal vein thrombosis) radiologically confirmed with ultrasound,
CT-scan, or MRI-scan
- Treatment with edoxaban 60mg 1dd as per the treating gastroenterologist

Exclusion Criteria

- Inability to provide informed conesent
- Active malignancy or infection
- Grade III/IV hepatic encephalopathy
- Cognitive disorders or other unfavorable conditions at discretion of treating
physician.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be a comparison of edoxaban area under the plasma<br /><br>concentration curve (AUC), maximum concentration (Cmax), a thrombin generation<br /><br>test and several other pharmacokinetic and pharmacodynamics parameters between<br /><br>patients with Child-Pugh A and Child-Pugh B cirrhosis and patients without<br /><br>cirrhosis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable </p><br>