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Prospective, randomized, double-blind, placebo-controlled, crossover phase IIa study on the safety of EdoXaban in PortosinusOidal vaScUlar disorder (EXPOSURE)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513353-73-00
Acronym
EXPOSURE
Enrollment
56
Registered
2025-01-31
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Porto-Sinusoidal Vascular Disorder

Brief summary

Incidence of major bleedings (will be defined according to the International Society on Thrombosis and Haemostasis [ISTH])

Detailed description

To assess the preliminary efficacy of edoxaban treatment for the prevention of splanchnic vein thrombosis (SVT) development, To assess the effects of edoxaban treatment on spleen stiffness as a surrogate of portal hypertension severity measured before and after edoxaban treatment., To assess the preliminary efficacy of edoxaban treatment for the prevention of hepatic decompensation., To assess effects of edoxaban treatment on health-related quality of life.

Interventions

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of major bleedings (will be defined according to the International Society on Thrombosis and Haemostasis [ISTH])

Secondary

MeasureTime frame
To assess the preliminary efficacy of edoxaban treatment for the prevention of splanchnic vein thrombosis (SVT) development, To assess the effects of edoxaban treatment on spleen stiffness as a surrogate of portal hypertension severity measured before and after edoxaban treatment., To assess the preliminary efficacy of edoxaban treatment for the prevention of hepatic decompensation., To assess effects of edoxaban treatment on health-related quality of life.

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026