Esomeprazole magnesium trihydrate for Liver cirrhosis

Inclusion criteria

• {"criterion_text":"-Male or female adult (18 years) patient."}
• {"criterion_text":"-Provided written informed consent."}
• {"criterion_text":"-Liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and/or radiological signs)."}
• {"criterion_text":"-Hospitalized or recently hospitalized (0 to 42 days before baseline) with complicated liver cirrhosis."}
• {"criterion_text":"-PPI treatment for at least 28 days prior to screening"}
• {"criterion_text":"-PPI treatment with a single standard dose/day or less for a minimum of 7 days prior to screening."}
• {"criterion_text":"-Females/Males who agree to comply with the applicable contraceptive requirements of the protocol."}
• {"criterion_text":"-Non-pregnant, non-lactating females."}
• {"criterion_text":"-Ability to understand the patient information and to personally sign and date the informed consent to participate in the study, before completing any study related procedures."}
• {"criterion_text":"-The patient is co-operative and available for the entire study."}

Exclusion criteria

• {"criterion_text":"-Severe esophageal reflux disease (LA grade C or D) diagnosed by esophago-gastro-duodenoscopy (EGD) < 2 months prior to screening without PPI treatment for at least 8 weeks prior to screening."}
• {"criterion_text":"-Positive urine pregnancy test at screening or positive serum pregnancy test before the first treatment or is breast feeding."}
• {"criterion_text":"-Patient is not willing to use adequate contraceptive precautions during the study or for up to 5 days after the last scheduled dose of IMP."}
• {"criterion_text":"-Peptic ulcers diagnosed by EGD < 28 days prior to screening."}
• {"criterion_text":"-Endoscopic therapy for varices < 14 days prior to screening."}
• {"criterion_text":"-Life-expectancy < 1 year (at the discretion of the investigator) due to extrahepatic malignancies, metastasized hepatocellular carcinoma (HCC), or other severe extrahepatic-diseases. Importantly, HCC without extrahepatic metastases or a reduced life-expectancy < 1 year due to liver cirrhosis are not regarded as exclusion criteria."}
• {"criterion_text":"-Regular intake of non-steroidal anti-inflammatory drugs on a daily basis with the exemption of acetylsalicylic acid in a dosage of up to 100mg/day."}
• {"criterion_text":"-Patients with one or more of the following measurements at the time of screening or documented during 48 hours before screening: a. Body temperature > 38.5°C, or b. systolic blood pressure < 90 mmHg and tachycardia > 100 beats per minute, or c. ongoing catecholamine treatment higher than low dose norepinephrine ( 0.1 μg/kg/minute) (NB: terlipressin treatment for possible hepatorenal syndrome is not regarded as an exclusion criterion), or d. respiratory rate 22/minute."}
• {"criterion_text":"-Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other excipients of the investigational medicinal product (IMP; Nexium mups or Placebo)."}
• {"criterion_text":"-Ongoing therapy with nelfinavir."}
• {"criterion_text":"-Participating in a clinical trial or use of an IMP within 30 days or five times the half-life of the IMP (whichever is longer) prior to receive the first dose within this study."}

Primary endpoints

• {"endpoint_text":"-Time to first unplanned re-hospitalization* or death within 12 months after randomization (composite endpoint). *Exception: expected re-hospitalization for paracentesis in patients with a history of refractory ascites (without any other complication of cirrhosis) during a period of 30 days.","definition_or_measurement_approach":"Time-to-event composite endpoint measured as time from randomization to first unplanned re-hospitalization or death within 12 months (360 days) after randomization; exception for expected paracentesis re-hospitalisation within 30 days in patients with refractory ascites."}

Secondary endpoints

• {"endpoint_text":"-Death (all-cause and liver-related).","definition_or_measurement_approach":"Time to death; mortality rates (overall and liver-related) during follow-up."}
• {"endpoint_text":"-Unplanned re-hospitalization.","definition_or_measurement_approach":"Time to and rate of unplanned re-hospitalizations during follow-up."}
• {"endpoint_text":"-Any Infection and differentiated by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus infection, Sars-CoV-2-infection).","definition_or_measurement_approach":"Overall infection rates and site-specific infection rates assessed during follow-up; events categorised by infection type (including SBP, pneumonia, UTI, bloodstream infection, C. difficile, Norovirus, SARS-CoV-2)."}
• {"endpoint_text":"-Acute hepatic decompensation and ACLF.","definition_or_measurement_approach":"Occurrence and rate of acute hepatic decompensation and acute-on-chronic liver failure during follow-up."}
• {"endpoint_text":"-Upper and lower gastrointestinal bleeding event.","definition_or_measurement_approach":"Rate and sources of gastrointestinal bleeding events (upper and lower GI bleeding) recorded during follow-up."}
• {"endpoint_text":"-Experimental Endpoint: Changes of intestinal microbiota between baseline and day 90.","definition_or_measurement_approach":"Assessment of changes in intestinal microbiota composition between baseline and day 90; methods not detailed in CTIS record."}

Germany

Earliest CTIS Part Ii Submission Date

23-05-2024

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

397

Number Of Sites

19

Number Of Participants

476

Primary sponsor

Full Name

University Medical Center Hamburg-Eppendorf

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"1,12,5,6,8","organisation_type":"Hospital/Clinic/Other health care facility"}