BridgeMD
EXPOSURE Study
EU CTIS ID: 2024-513353-73-00
What this study is testing
To assess the safety and tolerability of edoxaban treatment in patients with PSVD
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (≥18 years) with histologically confirmed diagnosis of PSVD
- Preserved or mildly impaired liver function (corresponding to Child-Pugh-Stage A or B)
- Willing to provide written informed consent and participate in the study
- Effective bleeding prophylaxis if indicated
You likely can't join if
- Any previous or current thrombosis in the spleno-portal axis
- Transjugular intrahepatic portosystemic shunt or portosystemic shunt carrier
- 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
- Active bleeding, clinically significant risk of major bleeding or any other contraindication for anticoagulant treatment
- Pregnancy or lactation
- Ascites needing large-volume paracentesis
See the full eligibility criteria
- Adult patients (≥18 years) with histologically confirmed diagnosis of PSVD
- Preserved or mildly impaired liver function (corresponding to Child-Pugh-Stage A or B)
- Willing to provide written informed consent and participate in the study
- Effective bleeding prophylaxis if indicated
- Any previous or current thrombosis in the spleno-portal axis
- Transjugular intrahepatic portosystemic shunt or portosystemic shunt carrier
- 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
- Active bleeding, clinically significant risk of major bleeding or any other contraindication for anticoagulant treatment
- Pregnancy or lactation
- Ascites needing large-volume paracentesis
- Patients in need for repeated interventions (not including variceal band ligation)
- Any comorbidity resulting in a life expectancy <24 months
- Severe thrombocytopenia (platelets <40 G/L)
- Kidney failure (creatinine clearance <15mL / min)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.