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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49068

Enrollment

Registered

2020-06-09

Start date

2021-03-02

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

deep vein thrombosis Venous thrombosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Countries

Netherlands

Outcome results