Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

January 3, 2019

Primary Completion Date

December 1, 2022

Study Completion Date

December 1, 2022

Conditions
Liver Cirrhoses
Interventions
DRUG

Simvastatin

Simvastatin 20 mg/day for 12 months

DRUG

Rifaximin

Rifaximin 400/8 hours for 12 months

DRUG

Placebo of Simvastatin

Placebo of Simvastatin once a day for 12 months

DRUG

Placebo of Rifaximin

Placebo of Rifaximin/8 hours for 12 months

Trial Locations (14)

10129

San Giovanni Battista Hospital, Torino

35128

Padova University Hospital, Padua

60590

Universitatsklinikum Frankurt, Frankfurt

92110

Beajuon Hospital, Clichy

Unknown

University Hospitals Leuven, Leuven

Bologna University Hospital, Bologna

Hospital de Sant Pau, Barcelona

Hospital Moisés Broggi, Barcelona

Hospital Parc Taulí, Barcelona

Hospital Gregorio Marañón, Madrid

1105 AZ

Academic Medical Centre, Amsterdam

08036

Hospital Clínic de Barcelona, Barcelona

08035

Hospital Universitari Vall d'Hebrón, Barcelona

NW3 2QG

Royal Free Hospital, London

All Listed Sponsors
lead

Judit Pich

OTHER

NCT03780673 - Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development | Biotech Hunter | Biotech Hunter