To assess the safety and effect of edoxaban in Chil-Pugh B cirrhosis.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
Patients with cirrhosis have an increased risk of developing venous
thromboembolism. Direct oral anticoagulants (DOACs) are easier to use than
subcutaneous low-molecular-weight heparin or vitamin K antagonists, but not
part of the treatment guidelines for venous thromboembolism in patients with
Child-Pugh B and C cirrhosis since they were excluded in the large phase III
trials. Based on previous retrospective and in-vitro studies on edoxaban in
Child-Pugh B cirrhosis, we hypothesise that edoxaban is safe for these
patients.
Study objective
To assess the safety and effect of edoxaban in Chil-Pugh B cirrhosis.
Study design
An open-label, prospective cohort study.
Study burden and risks
Patients will be seen in the hospital two times for a series of blood samples.
The first time they will come early in the morning and this visit will last
approximately five hours. Five blood samples will be taken. The second time wil
be planned during routine outpatient follow-up. the first samples will be taken
early in the morning (13.5ml) and the second two hours later (13.5ml). Besides
possible small hematomas, there is no additional risk in the study procedures.
van Riebeeckweg 212
Hilvesum 1213XZ
NL
van Riebeeckweg 212
Hilvesum 1213XZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71675.018.19 |