APIXABAN for Intrahepatic non-cirrhotic portal hypertension|Non-cirrhotic portal hypertension

Inclusion criteria

• {"criterion_text":"- >/=18 and ≤ 90 year old male and female patients\n- For child-bearing aged women, contraception using progestatives, or intrauterine device or mechanical contraception\n- Adequate prophylaxis against variceal bleeding according to EASL (European association for the study of the liver) guidelines\n- Intrahepatic non cirrhotic portal hypertension (INCPH), defined according to the recent VALDIG workshop (Feb. 2017, Ascona, Italy) as having one of the following simultaneous associations: a.\tabsence of cirrhosis on an adequate liver biopsy, and one or more signs specific for portal hypertension b.\tabsence of cirrhosis on an adequate liver biopsy, and one or more signs not specific for portal hypertension and one or more histological signs for INCPH c.\tin the absence of adequate liver biopsy, 2 reliable liver stiffness values determined using transient elastography (Fibroscan) < 10 kPa and one or more signs specific for portal hypertension"}

Exclusion criteria

• {"criterion_text":"- o\tMyeloproliferative disease treated with aspirin to prevent vascular events, paroxysmal nocturnal hemoglobinuria.\n- o\tActive clinically significant bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.\n- o\tPlatelet < 40000/mm3, or prothrombin index <40% in the absence of anti-vitamin K or Factor V < 40% or Fibrinogen < 1.0g/L\n- o\tTransjugular intrahepatic portosystemic shunt (TIPSS) or surgical portosystemic shunt\n- o\tParticipation in another interventional trial\n- o\tCreatinine clearance < 30 mL/min\n- o\tHepatitis C with detectable HCV RNA at inclusion\n- o\tPositive HBs Ag, except patients with HBeAg-negative chronic HBV infection, previously termed ‘inactive carriers’ [characterised by the presence of serum antibodies to HBeAg (anti-HBe), undetectable or low (<2,000 IU/mL) HBV DNA levels and normal serum ALT levels] that can be included\n- o\tAlcohol intake >210 g/week for men and 140 g/week for women\n- o\tMandatory indicationb to aspirin or other antiplatelet agents including P2Y12 receptor antagonists\n- o\tPatient who underwent liver transplantation less than 3 years before screening\n- o\tOngoing oestroprogestative contraception\n- o\tSevere hepatic impairment or significant active liver injury (serum ALT level > 5 times the upper limit of normal values)\n- o\tLife expectancy <12 months\n- o\tSpecific causes of portal hypertension or specific vascular liver diseases: history of bone marrow transplantation, Budd-Chiari syndrome / hepatic venous outflow obstruction, hepatic schistosomiasis diagnosed on liver biopsy (an isolated positive serology is not an exclusion criterion), cardiac failure, Fontan surgery, Abernethy syndrome, Hereditary hemorrhagic telangiectasia, chronic cholestatic diseases, liver infiltration by tumor cells\n- o\tConcomitant use of potent inhibitors of CYP3A4 or P-gp. In case of moderate interactions with apixaban (for example, immunosuppressive treatment), the dose of CYP3A4 inhibitor will be adapted according to its plasmatic level in the study patient.\n- o\tHypersensitivity to the active substance or to any of the excipients including lactose.\n- o\tPatients unable to give consent (under guardianship or curatorship)\n- o\tNo written informed consent for participation in the study\n- o\tNo coverage for medical insurance\n- o\tPregnant or breastfeeding women\n- o\tComplete thrombosis of superior mesenteric vein and/or inferior mesenteric vein\n- o\tComplete portal vein thrombosis or portal cavernoma\n- o\tRecent (<6 months) partial portal venous system thrombosis\n- o\tMandatory indicationa or contraindication to anticoagulation\n- o\tConcomitant treatment with any other anticoagulant agent unless when bridging from one to the other is performed\n- o\tDisease at high risk of bleeding (except for portal hypertension)"}

Primary endpoints

• {"endpoint_text":"- Within 24 months after randomisation, cumulative incidence of occurrence or progression (according to VALDIG PVT criteria) of portal venous system thrombosis (including splenic and/or superior mesenteric vein and/or inferior mesenteric vein and/or portal trunk and/or one of the 2 portal branches), determined using a CT scan with centralized imaging blinded review","definition_or_measurement_approach":"Occurrence or progression assessed within 24 months after randomisation according to VALDIG PVT criteria, determined by CT scan with centralized blinded imaging review."}

France

Earliest CTIS Part Ii Submission Date

02-07-2024

Latest Decision Or Authorization Date

28-10-2025

Processing Time Days

483

Number Of Sites

15

Number Of Participants

166

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Ministry","duties_or_roles":"Source of monetary support","organisation_type":""}