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APIS Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension
EU CTIS ID: 2024-514348-95-00
What this study is testing
To evaluate the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the progression of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months in patients with INCPH
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - >/=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
You likely can't join if
- o Myeloproliferative disease treated with aspirin to prevent vascular events, paroxysmal nocturnal hemoglobinuria.
- o Active 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.
- o Platelet < 40000/mm3, or prothrombin index <40% in the absence of anti-vitamin K or Factor V < 40% or Fibrinogen < 1.0g/L
- o Transjugular intrahepatic portosystemic shunt (TIPSS) or surgical portosystemic shunt
- o Participation in another interventional trial
- o Creatinine clearance < 30 mL/min
See the full eligibility criteria
Who can join
- - >/=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
What rules you out
- o Myeloproliferative disease treated with aspirin to prevent vascular events, paroxysmal nocturnal hemoglobinuria.
- o Active 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.
- o Platelet < 40000/mm3, or prothrombin index <40% in the absence of anti-vitamin K or Factor V < 40% or Fibrinogen < 1.0g/L
- o Transjugular intrahepatic portosystemic shunt (TIPSS) or surgical portosystemic shunt
- o Participation in another interventional trial
- o Creatinine clearance < 30 mL/min
- o Hepatitis C with detectable HCV RNA at inclusion
- o Positive 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
- o Alcohol intake >210 g/week for men and 140 g/week for women
- o Mandatory indicationb to aspirin or other antiplatelet agents including P2Y12 receptor antagonists
- o Patient who underwent liver transplantation less than 3 years before screening
- o Ongoing oestroprogestative contraception
- o Severe hepatic impairment or significant active liver injury (serum ALT level > 5 times the upper limit of normal values)
- o Life expectancy <12 months
- o Specific 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
- o Concomitant 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.
- o Hypersensitivity to the active substance or to any of the excipients including lactose.
- o Patients unable to give consent (under guardianship or curatorship)
- o No written informed consent for participation in the study
- o No coverage for medical insurance
- o Pregnant or breastfeeding women
- o Complete thrombosis of superior mesenteric vein and/or inferior mesenteric vein
- o Complete portal vein thrombosis or portal cavernoma
- o Recent (<6 months) partial portal venous system thrombosis
- o Mandatory indicationa or contraindication to anticoagulation
- o Concomitant treatment with any other anticoagulant agent unless when bridging from one to the other is performed
- o Disease at high risk of bleeding (except for portal hypertension)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.