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Study on Norfloxacin for Reducing Portal Hypertension in Patients with Decompensated Cirrhosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called norfloxacin on two liver-related conditions: portal hypertension and decompensated cirrhosis. Portal hypertension is a condition where there is increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver. Decompensated cirrhosis is a severe stage of liver disease where the liver is significantly damaged and cannot function properly. The study will use a medication called Floxacin 400 mg Filmtabletten, which contains the active ingredient norfloxacin, and compare its effects to a placebo, which is a substance with no active medication.

The purpose of the study is to determine if treatment with norfloxacin can reduce portal hypertension in patients with decompensated cirrhosis. Participants in the study will be randomly assigned to receive either norfloxacin or a placebo. The study will last for 12 weeks, during which time the effects of the treatment on portal hypertension will be monitored. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, researchers will also observe the occurrence of liver-related complications and monitor various health indicators, such as biomarkers of bacterial translocation and systemic inflammation, as well as patient-reported outcomes related to quality of life. The study aims to provide valuable insights into the potential benefits of norfloxacin for patients with these liver conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent, confirming your willingness to participate and understanding of the study procedures.

  2. Step 2

    Initial assessment

    You will undergo a liver vein catheterization procedure to measure the hepatic venous pressure gradient (HVPG). This measurement helps assess the level of portal hypertension, a condition related to increased blood pressure in the veins coming from the stomach, intestine, spleen, and pancreas to the liver.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either the medication norfloxacin or a placebo. Norfloxacin is provided in the form of a 400 mg film-coated tablet, taken orally. The placebo consists of gelatin capsules filled with maltodextrin, which is a harmless substance with no active medication.

    You will take the assigned tablet once daily for a duration of 12 weeks.

  4. Step 4

    Follow-up assessments

    Throughout the 12-week period, your health will be monitored regularly. This includes checking for any liver-related complications and assessing your overall health and quality of life using questionnaires.

    At the end of the 12 weeks, the HVPG measurement will be repeated to evaluate any changes in portal hypertension.

  5. Step 5

    Post-treatment evaluation

    After completing the 12-week medication period, additional assessments will be conducted at 24 weeks to monitor any long-term effects. These assessments will include checking for liver-related complications, evaluating biomarkers, and analyzing stool and blood samples.

Who can join the trial?

4 criteria

  • Patients must have **decompensated cirrhosis**. This is a condition where the liver is severely damaged and cannot function properly.
  • Patients must be undergoing a procedure called **liver vein catheterization**. This is a test to measure the pressure in the liver veins.
  • Patients must be between **18 and 80 years old**.
  • Patients must provide **written informed consent**. This means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

2 criteria

  • Patients with **portal hypertension** cannot participate. This is a condition where there is increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver.
  • Patients with **decompensated cirrhosis** are excluded. This is a severe stage of liver disease where the liver is significantly damaged and cannot function properly.
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Investigated drugs

Norfloxacin is an antibiotic that is being tested in this clinical trial to see if it can help reduce a condition called portal hypertension in people with decompensated cirrhosis. Portal hypertension is when there is increased blood pressure in the veins that carry blood from the digestive organs to the liver. This condition can lead to serious health problems. The trial aims to find out if taking norfloxacin for 12 weeks can lower this blood pressure and improve the health of patients with liver issues.

What is already known about the treatment

Norfloxacin – Norfloxacin is an antibiotic that is taken orally in the form of tablets. It is currently being studied in clinical trials to see if it can help reduce portal hypertension, which is high blood pressure in the veins that carry blood to the liver, in patients with decompensated cirrhosis, a severe liver condition. The main therapeutic use being investigated is its potential to lower this specific type of blood pressure. At the molecular level, norfloxacin works by inhibiting bacterial DNA replication, which helps reduce bacterial infections that can worsen liver conditions. It belongs to the pharmacological class of fluoroquinolone antibiotics.

Investigated diseases

  • Portal Hypertension

    Portal hypertension is a condition characterized by increased blood pressure within the portal venous system, which includes the veins coming from the stomach, intestine, spleen, and pancreas that merge into the portal vein. This condition often arises due to obstruction or increased resistance to blood flow through the liver, commonly caused by liver cirrhosis. As the pressure builds, it can lead to the development of varices, which are enlarged veins that can rupture and bleed. Over time, portal hypertension can result in complications such as ascites, which is the accumulation of fluid in the abdominal cavity, and splenomegaly, an enlargement of the spleen. The progression of portal hypertension can also lead to hepatic encephalopathy, a decline in brain function due to liver dysfunction.

  • Decompensated Cirrhosis

    Decompensated cirrhosis is an advanced stage of liver cirrhosis where the liver can no longer perform its vital functions adequately. This stage is marked by the onset of complications such as jaundice, ascites, variceal hemorrhage, and hepatic encephalopathy. The liver's inability to filter toxins from the blood leads to a buildup of harmful substances, affecting various body systems. As the disease progresses, patients may experience muscle wasting, severe fatigue, and increased susceptibility to infections. Decompensated cirrhosis often results from chronic liver damage due to conditions like hepatitis or long-term alcohol abuse. The progression of this disease can significantly impact the quality of life and requires careful management to address the complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513352-15-00Protocol codeNOPEEstimated enrolment150 patientsSponsorMedical University Of Vienna

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