Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

PHASE4RecruitingINTERVENTIONAL
Enrollment

238

Participants

Timeline

Start Date

January 21, 2020

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
Hepatic EncephalopathyCirrhosis, LiverPortal HypertensionLiver DiseasesPathological Processes
Interventions
DRUG

Rifaximin 550 milligram Oral Tablet [XIFAXAN]

Rifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS

DRUG

Placebo oral tablet

Placebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS

DRUG

Lactulose 667 milligram/milliliter Oral Solution

Lactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS

Trial Locations (6)

Unknown

RECRUITING

Universitaire Ziekenhuizen Leuven, Leuven

RECRUITING

Academic Medical Centre, Amsterdam

RECRUITING

University Medical Center Groningen, Groningen

RECRUITING

Leiden University Medical Center, Leiden

RECRUITING

Radboud University, Nijmegen

RECRUITING

Erasmus Medical Center, Rotterdam

Sponsors
All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

Leiden University Medical Center

OTHER

collaborator

Maastricht University Medical Center

OTHER

collaborator

Radboud University Medical Center

OTHER

collaborator

University Medical Center Groningen

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

Norgine

INDUSTRY

lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER