Edoxaban for Porto-sinusoidal vascular disorder

Inclusion criteria

• {"criterion_text":"- Adult patients (≥18 years) with histologically confirmed diagnosis of PSVD\n- Preserved or mildly impaired liver function (corresponding to Child-Pugh-Stage A or B)\n- Willing to provide written informed consent and participate in the study\n- Effective bleeding prophylaxis if indicated"}

Exclusion criteria

• {"criterion_text":"- Any previous or current thrombosis in the spleno-portal axis\n- Transjugular intrahepatic portosystemic shunt or portosystemic shunt carrier\n- Current indication for therapeutic anticoagulation (e.g., atrial fibrillation, deep vein thrombosis, pulmonary embolism, etc.). Note: Patients with an indication for prophylactic anticoagulation will be allowed for this study\n- Active bleeding, clinically significant risk of major bleeding or any other contraindication for anticoagulant treatment\n- Pregnancy or lactation\n- Ascites needing large-volume paracentesis\n- Patients in need for repeated interventions (not including variceal band ligation)\n- Any comorbidity resulting in a life expectancy <24 months\n- Severe thrombocytopenia (platelets <40 G/L)\n- Kidney failure (creatinine clearance <15mL / min)"}

Primary endpoints

• {"endpoint_text":"- Incidence of major bleedings (will be defined according to the International Society on Thrombosis and Haemostasis [ISTH])","definition_or_measurement_approach":"Major bleedings will be defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria."}

Secondary endpoints

• {"endpoint_text":"- To assess the preliminary efficacy of edoxaban treatment for the prevention of splanchnic vein thrombosis (SVT) development","definition_or_measurement_approach":""}
• {"endpoint_text":"- To assess the effects of edoxaban treatment on spleen stiffness as a surrogate of portal hypertension severity measured before and after edoxaban treatment.","definition_or_measurement_approach":"Spleen stiffness measured before and after edoxaban treatment (measurement method not further specified in provided data)."}
• {"endpoint_text":"- To assess the preliminary efficacy of edoxaban treatment for the prevention of hepatic decompensation.","definition_or_measurement_approach":""}
• {"endpoint_text":"- To assess effects of edoxaban treatment on health-related quality of life.","definition_or_measurement_approach":""}

Austria

Earliest CTIS Part Ii Submission Date

19-12-2024

Latest Decision Or Authorization Date

31-01-2025

Processing Time Days

43

Number Of Sites

1

Number Of Participants

56

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"Ludwig Boltzmann Society","duties_or_roles":"Source of monetary support","organisation_type":""}