Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
Intrahepatic non-cirrhotic portal hypertension (INCPH) is a rare disease mostly affecting
adults in their forties, characterized by portal hypertension related to alterations of
intrahepatic microcirculation in the absence of cirrhosis.The only therapeutic options
currently available for patients with INCPH include prophylaxis for variceal bleeding using
betablockers and/or endoscopic band ligation and TIPSS (transjugular intrahepatic
portosystemic shunt) or liver transplantation for severe cases.
The investigators hypothesize that anticoagulation using Apixaban in patients with INCPH
might prevent occurrence or extension of portal, splenic or mesenteric veins thromboses and
thus the development of chronic portal vein thrombosis and associated complications, but also
avoid intrahepatic thromboses and consequently liver disease progression and variceal
bleeding.
The Primary Objective is to evaluate the effect of 24 months low dosing of apixaban (2.5 mg x
2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis
(including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24
months in patients with INCPH.
166 patients will be included in 16 centers in a prospective, national multicentric, phase
III, superiority comparative randomized (1:1) double-blinded clinical trial with two parallel
arms: apixaban versus placebo.