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

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What is this study about?

The EXPOSURE Study is focused on understanding the safety of a medication called edoxaban in people with a condition known as Porto-Sinusoidal Vascular Disorder (PSVD). This condition affects the blood vessels in the liver, which can lead to complications. The study will compare the effects of edoxaban, which is taken as a tablet, with a placebo, which looks like the medication but does not contain the active ingredient.

The main goal of the study is to see how safe and tolerable edoxaban is for patients with PSVD. Participants will take part in a randomized, double-blind trial, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will also look at how edoxaban might help prevent certain complications, such as blood clots in the veins around the liver, and how it affects the stiffness of the spleen, which can be a sign of increased pressure in the liver’s blood vessels.

Throughout the study, participants will be monitored for any major bleeding events, as well as other health outcomes like liver function and quality of life. The study aims to provide valuable information on the potential benefits and risks of using edoxaban in treating PSVD, which could help improve care for patients with this condition in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of porto-sinusoidal vascular disorder (PSVD) and ensuring liver function is preserved or only mildly impaired.

Eligibility criteria also require participants to be adults aged 18 or older and to have provided written informed consent.

2 randomization and treatment assignment

Participants are randomly assigned to receive either the active medication or a placebo. The active medication is edoxaban, available in two dosages: 60 mg and 30 mg film-coated tablets.

The placebo consists of gelatine capsules filled with maltodextrin.

3 medication administration

The medication, whether active or placebo, is taken orally. The specific dosage and frequency are determined by the study protocol and are administered under double-blind conditions, meaning neither the participant nor the study team knows which treatment is being given.

4 monitoring and follow-up

Participants are monitored for any major bleeding incidents, as defined by the International Society on Thrombosis and Haemostasis.

Additional assessments include evaluating the preliminary efficacy of edoxaban in preventing splanchnic vein thrombosis, assessing spleen stiffness, and monitoring for signs of hepatic decompensation.

The impact of the treatment on health-related quality of life is also evaluated.

5 crossover phase

The study includes a crossover phase, where participants who initially received the placebo may switch to the active medication, or vice versa, to further assess the safety and tolerability of edoxaban.

6 study completion

The study is expected to conclude by September 30, 2030. Participants will have completed all required assessments and follow-ups by this date.

Who Can Join the Study?

Adult patients who are 18 years or older with a confirmed diagnosis of Porto-Sinusoidal Vascular Disorder (PSVD). This means a doctor has checked and confirmed the condition through a tissue sample.
Patients must have either normal or only slightly reduced liver function. This is measured by something called the Child-Pugh Score, which is a way to check how well the liver is working. Patients should be in Stage A or B, which means the liver is working fairly well.
Patients must be willing to sign a document that says they understand the study and agree to take part. This is called giving written informed consent.
If needed, patients should have effective measures in place to prevent bleeding. This is known as bleeding prophylaxis.

Who Cannot Join the Study?

Patients who are not diagnosed with Porto-Sinusoidal Vascular Disorder cannot participate. This is a condition affecting the blood vessels in the liver.
Patients who are outside the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
Patients who are not willing to follow the study procedures cannot participate. This means you need to agree to follow the rules of the study.
Patients who have other medical conditions that might interfere with the study cannot participate. This is to ensure the safety and accuracy of the study results.
Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and baby.
Patients who are taking medications that might interfere with the study cannot participate. This is to ensure the study results are not affected by other treatments.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	31.10.2024

Trial locations

Investigated drugs:

Edoxaban

Edoxaban is a medication used in this clinical trial to evaluate its safety and tolerability in patients with a specific vascular disorder. It is an anticoagulant, which means it helps prevent blood clots from forming. This medication is being tested to see if it can be safely used in patients with portosinusoidal vascular disorder (PSVD), a condition affecting blood flow in the liver.

Investigated diseases:

Porto-sinusoidal vascular disorder

Porto-Sinusoidal Vascular Disorder – This is a condition affecting the liver’s blood vessels, specifically the small veins within the liver. It leads to changes in the blood flow through the liver, which can cause increased pressure in the portal vein, known as portal hypertension. Over time, this increased pressure can result in the development of enlarged veins, or varices, in the esophagus or stomach, which may lead to bleeding. The disorder can also cause an enlarged spleen and a reduction in the number of blood cells. Symptoms may include fatigue, abdominal discomfort, and signs of portal hypertension. The progression of the disease can vary, with some individuals experiencing more severe symptoms than others.

Trial ID:

2024-513353-73-00

Protocol code:

EXPOSURE

Trial Phase:

Therapeutic exploratory (Phase II)

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

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