Stop of long-term suppression of gastric acid with proton-pump inhibitors in patients with liver cirrhosis

Phase 1

• Conditions: iver cirrhosis; MedDRA version: 20.0Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 20.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 20.0Level: PTClassification code 10003445Term: AscitesSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1Level: LLTClassification code 10051156Term: Ascites infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10068547Term: BacterascitesSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10068555Term: Monomicrobial non-neutrocytic bacterascitesSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 24.1Level: PTClassification code 10061135Term: Spontaneous bacterial peritonitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10019660Term: Hepatic encephalopathySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: HLTClassification code 10036201Term: Portal hypertensionsSystem Organ Class: 100000004866

• Registration Number: EUCTR2019-005008-16-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-04
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

1. Male or female adult (=18 years) patient.
2. Liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and/or radiological signs).
3. Hospitalized or recently hospitalized (up to 42 days before baseline) with complicated liver cirrhosis.
4. PPI treatment for at least 28 days prior to the screening visit.
5. PPI treatment with a single standard dose/day or less for a minimum of 7 days prior to the screening visit. Standard doses of the different PPIs are defined in the protocol.
6. Females/Males who agree to comply with the applicable contraceptive requirements, which are specified in the protocol.
7. Non-pregnant, non-lactating females.
8. 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.
9. The patient is co-operative and available for the entire study.
10. The patient provided written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 376
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

The exclusion criteria of the trial are as follows:
1. 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. Details on the LA classification-system are provided in the protocol.
2. Peptic ulcers diagnosed by EGD < 28 days prior to screening.
3. Endoscopic therapy for varices < 14 days prior to screening.
4. 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.
5. Regular intake of non-steroidal anti-inflammatory drugs (NSAID) on a daily basis with the exemption of acetylsalicylic acid in a dosage of up to 100mg/day.
6. Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other exipients of the IMP (Nexium mups or placebo).
7. Ongoing therapy with nelfinavir.
8. Participating in a clinical trial or use of an investigantional medical product (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.
9. Positive urine pregnancy test at screening or positive serum pregnancy test before the first treatment or is breast feeding.
10. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified