Porto-sinusoidal vascular disorder Trials in Disease

Study on the Safety of Edoxaban for Patients with Porto-Sinusoidal Vascular Disorder

This study, known as the EXPOSURE Study, is examining whether edoxaban is safe and well-tolerated for people living with Porto-Sinusoidal Vascular Disorder. The condition affects small blood vessels in the liver, which can lead to complications such as increased pressure in the portal vein, blood clots, and an enlarged spleen.

Main inclusion criteria:

• Adults aged 18 years or older
• Confirmed diagnosis of Porto-Sinusoidal Vascular Disorder verified through tissue sampling
• Normal or only mildly reduced liver function (Child-Pugh Score Stage A or B)
• Willingness to provide written informed consent
• If needed, effective bleeding prevention measures should be in place

Main exclusion criteria:

• Absence of confirmed diagnosis
• Pregnancy or breastfeeding
• Other medical conditions that might interfere with the study
• Use of medications that could affect study results
• Unwillingness to follow study procedures

Study focus and goals:

The main goal is to evaluate the safety and tolerability of edoxaban compared to placebo in patients with this vascular disorder. The trial uses a randomized, double-blind design, meaning neither participants nor researchers know who receives the actual medication or the placebo during the study.

Researchers will carefully monitor participants for any major bleeding events, as this is the primary safety concern with anticoagulant medications. The study will also examine whether edoxaban can help prevent blood clots in the veins around the liver, reduce spleen stiffness (which indicates pressure in liver blood vessels), and prevent liver decompensation. Quality of life measurements will also be tracked throughout the study.

The trial includes a crossover phase, where participants may switch from placebo to active medication or vice versa, providing additional safety data. The study is expected to conclude by September 30, 2030.

Investigational drug:

Edoxaban is the medication being tested in this trial. It is an oral anticoagulant taken as a tablet, available in two doses: 60 mg and 30 mg. Edoxaban works by blocking Factor Xa, an enzyme that plays a crucial role in blood clot formation. By inhibiting this enzyme, edoxaban reduces the risk of clot-related complications. It belongs to a class of medications called direct oral anticoagulants, or DOACs.