APIS Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514348-95-00

Acronym

P170916J

Enrollment

166

Registered

2024-07-10

Start date

2019-06-24

Completion date

Unknown

Last updated

2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic non-cirrhotic portal hypertension

Brief summary

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

Interventions

DRUGPlacebo of Eliquis 2.5 mg

DRUGEliquis 2.5 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026