APISApixaban for Intrahepatic Non Cirrhotic Portal Hypertensio

Phase 1

• Conditions: Intrahepatic non-cirrhotic portal hypertension; MedDRA version: 20.1Level: PTClassification code: 10077259Term: Non-cirrhotic portal hypertension Class: 100000004871; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2024-514348-95-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

>/=18 and = 90 year old male and female patients, - For child-bearing aged women, contraception using progestatives, or intrauterine device or mechanical contraception, - Adequate prophylaxis against variceal bleeding according to EASL (European association for the study of the liver) guidelines, - 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.absence of cirrhosis on an adequate liver biopsy, and one or more signs specific for portal hypertension b.absence 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.in 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

oMyeloproliferative disease treated with aspirin to prevent vascular events, paroxysmal nocturnal hemoglobinuria., oActive 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., oPlatelet < 40000/mm3, or prothrombin index <40% in the absence of anti-vitamin K or Factor V < 40% or Fibrinogen < 1.0g/L, oTransjugular intrahepatic portosystemic shunt (TIPSS) or surgical portosystemic shunt, oParticipation in another interventional trial, oCreatinine clearance < 30 mL/min, oHepatitis C with detectable HCV RNA at inclusion, oPositive 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, oAlcohol intake >210 g/week for men and 140 g/week for women, oMandatory indicationb to aspirin or other antiplatelet agents including P2Y12 receptor antagonists, oPatient who underwent liver transplantation less than 3 years before screening, oOngoing oestroprogestative contraception, oSevere hepatic impairment or significant active liver injury (serum ALT level > 5 times the upper limit of normal values), oLife expectancy <12 months, oSpecific 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, oConcomitant 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., oHypersensitivity to the active substance or to any of the excipients including lactose., oPatients unable to give consent (under guardianship or curatorship), oNo written informed consent for participation in the study, oNo coverage for medical insurance, oPregnant or breastfeeding women, oComplete thrombosis of superior mesenteric vein and/or inferior mesenteric vein, oComplete portal vein thrombosis or portal cavernoma, oRecent (<6 months) partial portal venous system thrombosis, oMandatory indicationa or contraindication to anticoagulation, oConcomitant treatment with any other anticoagulant agent unless when bridging from one to the other is performed, oDisease at high risk of bleeding (except for portal hypertension)

Study & Design

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