NORFLOXACIN for Portal hypertension | Decompensated cirrhosis

Inclusion criteria

• {"criterion_text":"- Patients with dACLD undergoing liver vein catheterization for measurement of hepatic venous pressure gradient"}
• {"criterion_text":"- Age 18-80 years"}
• {"criterion_text":"- Written informed consent to participate in the study"}

Exclusion criteria

• {"criterion_text":"- Lack of ability to give consent or unwillingness to participate in the study"}
• {"criterion_text":"- Pregnancy or unwillingness to utilize effective means of contraception for the duration of the study in women of childbearing potential"}
• {"criterion_text":"- QTc >480 ms at study screening"}
• {"criterion_text":"- Serum creatinine >1.5 mg/dL at study screening or chronic hemodialysis"}
• {"criterion_text":"- Bilirubin >5 mg/dL at study screening"}
• {"criterion_text":"- High paracentesis frequency"}
• {"criterion_text":"- Initiation of hepatitis C virus (HCV) or hepatitis B virus (HBV) treatment within the last year"}
• {"criterion_text":"- Non-cirrhotic portal hypertension (e.g. PSVD)"}
• {"criterion_text":"- Malignant diseases including hepatocellular carcinoma (HCC) at enrollment"}
• {"criterion_text":"- Immunosuppression"}
• {"criterion_text":"- Untreated/uncontrolled HIV infection"}
• {"criterion_text":"- Long-term administration of antibiotic medication at study enrollment"}
• {"criterion_text":"- Allergy to norfloxacin or other quinolones"}
• {"criterion_text":"- Risk of incompliance/lack of adherence to the study protocol (at the investigator’s discretion)"}

Primary endpoints

• {"endpoint_text":"- Change in HVPG at 12 weeks compared to baseline in the treatment group as compared to placebo","definition_or_measurement_approach":"Change in hepatic venous pressure gradient (HVPG) measured at baseline and at 12 weeks; comparison of change from baseline between norfloxacin and placebo arms."}

Secondary endpoints

• {"endpoint_text":"- Incidence of liver-related complications at 12 weeks and at 24 weeks (Spontaneous bacterial peritonitis, Hepatorenal syndrome, Variceal bleeding, Jaundice, Large-volume ascites, Overt hepatic encephalopathy, Any other major infection (pneumonia, sepsis…), Acute-on-chronic liver failure (ACLF), Liver-related death)","definition_or_measurement_approach":"Incidence counts of predefined liver-related complications assessed at 12 and 24 weeks; events captured per trial case report forms and safety reporting."}
• {"endpoint_text":"- Liver-related mortality","definition_or_measurement_approach":"Deaths adjudicated as liver-related during study follow-up (timepoints include 12 and 24 weeks where applicable)."}
• {"endpoint_text":"- Biomarkers of bacterial translocation and systemic inflammation at 12 weeks (on-drug) and at 24 weeks (off-drug)","definition_or_measurement_approach":"Laboratory measurement of predefined biomarkers of bacterial translocation and systemic inflammation at week 12 (on treatment) and week 24 (off treatment)."}
• {"endpoint_text":"- Patient-reported outcomes/HRQoL (using validated questionnaires: SF-36 v2.0, CLDQ, FSS) at 12 weeks (on-drug) and at 24 weeks (off-drug)","definition_or_measurement_approach":"Patient-reported outcome instruments (SF-36 v2.0, CLDQ, FSS) administered at baseline, week 12 and week 24 to assess health-related quality of life and fatigue."}
• {"endpoint_text":"- Stool microbiome composition at baseline vs. week 12","definition_or_measurement_approach":"Microbiome profiling of stool samples collected at baseline and week 12; comparison of composition changes."}
• {"endpoint_text":"- Blood metabolomic signatures at baseline vs. week 12","definition_or_measurement_approach":"Metabolomic profiling of blood samples at baseline and week 12 to identify signature changes."}

Austria

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

09-12-2024

Processing Time Days

34

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"Ludwig Boltzmann Society","duties_or_roles":"Source of monetary support","organisation_type":""}