Status:
RECRUITING
Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
German Federal Ministry of Education and Research
University Hospital Heidelberg
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Proton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
476 Patients enrolled
Trial Details
Trial ID
NCT04448028
Start Date
April 22 2021
End Date
February 1 2028
Last Update
April 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany, 20246