Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Jun 24, 2020

Keywords

ClinConnect Summary

The STOPPIT trial is investigating whether stopping long-term treatment with proton-pump inhibitors (PPIs) can help patients with liver cirrhosis avoid hospital readmissions and improve their overall health. PPIs are often used to reduce stomach acid, but there are concerns that they might increase the risk of infections and other complications in cirrhotic patients. In this study, 476 participants who have been hospitalized for liver issues and have been on PPIs for at least four weeks will be divided into two groups: one will stop their PPI treatment and receive a placebo, while the other will continue taking the medication for a year. The researchers want to see if stopping the PPIs leads to better outcomes, including fewer hospital visits and lower rates of infections.

To be eligible for the trial, participants must have liver cirrhosis, be recently hospitalized due to complications, and have been on PPIs for at least 28 days. However, those who have severe reflux, peptic ulcers, or other serious health issues may not qualify. Throughout the study, participants will be monitored closely to track their health and any potential side effects. This trial is important because it aims to clarify the risks and benefits of PPI use in people with liver cirrhosis, which could guide future treatment decisions for these patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with liver cirrhosis. The diagnosis of liver cirrhosis may be based on histology or a combination of clinical, laboratory and radiological criteria.
• • Hospitalization or recent hospitalization (0 to 42 days prior to the baseline visit) with complications of liver cirrhosis.
• • Treatment with proton pump inhibitors (PPI) for at least 28 days prior to the screening visit.
• • PPI treatment with a single standard dose/day or less for at least 7 days prior to the screening visit.
• • Females/males who agree to comply with the applicable contraceptive requirements of the protocol.
• • Non-pregnant, non-lactating females.
• • 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.
• • The patient is co-operative and available for the entire study.
• • Provided written informed consent.
• Exclusion Criteria:
• • Diagnosis of severe reflux esophagitis (LA grade C or D) by EGD \< 2 months prior to the screening visit without PPI-therapy for at least 8 weeks prior to the screening visit.
• • Peptic ulcers diagnosed by EGD \< 28 days prior to the screening visit.
• • History of endoscopic therapy for esophageal varices \< 14 days prior to the screening visit.
• • 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 of \< 1 year due to liver cirrhosis are not regarded as exclusion criteria.
• • Regular intake of non-steroidal anti-inflammatory drugs (NSAID) on a daily basis with the exemption of acetylsalicylic acid (ASS) 100mg/day orally.
• • Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other excipients of the IMP.
• • Ongoing therapy with nelfinavir.
• • Participation 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 receiving the first dose within this study.
• • Positive urine pregnancy test at screening or positive serum pregnancy test before the first treatment or is breast feeding.
• • Patient is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of IMP.