Study to evaluate the effect of rivaroxaban in patients with advanced liver disease with portal vein thrombosis

Phase 1

• Conditions: iver cirrhosis and portal vein thrombosis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003240-37-ES
• Lead Sponsor: Fundación para la Investigación Biomédica Hospital Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-09
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

- Age 18-75 years.
- Hepatic cirrhosis.
- Thrombosis splenoportal axis: 1) >25% on any of the three main vessels (the main trunk of the portal vein, superior mesenteric vein, splenic vein) 2) Thrombosis affects > 50% of at least one of the intrahepatic branches.
- Nonterminal Hepatic failure: B7-C12 state in Child-Pugh classification.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

?Thrombosis: <25% of a single vessel of the splenoportal axis.
?Patient on the waiting list or evaluation for liver transplantation.
?Portal cavernoma (chronic and complete occlusion of the portal vein accompanied by a network of small venous vessels).
?Antiplatelet and/or anticoagulant therapy at the time of inclusion.
?Platelet count equal or less than 30,000 platelets/mm3.
?Renal failure (creatinine clearance <15 ml/min).
?Severe or terminal liver failure (= 13 points Child-Pugh classification).
?Active intra or extrahepatic neoplasia.
?Clinically significant active bleeding.
?Alcohol consumption = 60 g/day in men and = 40 g/day in women.
?Pregnancy- lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified