#1 Clinical Trials Search in Europe

Study on Rifaximin for Delaying Hepatic Encephalopathy in Cirrhosis Patients

3 1

What is this study about?

This clinical trial is focused on studying a condition known as Hepatic Encephalopathy, which is a complication that can occur in people with liver cirrhosis. The trial is investigating the use of a medication called Rifaximin, specifically in the form of 40 mg Soluble Solid Dispersion Immediate Release Tablets (SSD-40IR). The purpose of the study is to determine if Rifaximin can help delay the worsening of symptoms associated with this condition, which often leads to hospitalization.

Participants in the study will be randomly assigned to receive either the Rifaximin tablets or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, during which participants will be monitored for any signs of their condition worsening, particularly those that might require hospitalization.

The main goal is to see how long it takes for participants to experience a significant event related to their condition, such as a hospitalization due to Hepatic Encephalopathy. The study will also look at other factors, such as the time it takes for any cause of hospitalization or serious health events to occur. This research aims to provide valuable information on the effectiveness and safety of Rifaximin in managing this serious liver-related condition.

1 joining the study

Upon joining the study, the participant will be required to provide written informed consent. This involves reading and understanding the consent form, which outlines the study’s purpose, procedures, and potential risks and benefits.

The participant must meet specific eligibility criteria, including having a diagnosis of liver cirrhosis with controlled ascites, a Conn score of less than 2, and a Mini-Mental State Examination score greater than 24.

2 initial assessment

An initial assessment will be conducted to confirm the participant’s eligibility. This includes a thorough medical evaluation and confirmation of the diagnosis of hepatic encephalopathy (OHE) by a trained medical professional.

A pregnancy test will be conducted for females of childbearing potential, and all participants must agree to use effective contraception methods during the study.

3 medication administration

Participants will be randomly assigned to receive either the study medication, rifaximin 40 mg soluble solid dispersion immediate release tablets (SSD-40IR), or a placebo. The medication is taken orally in tablet form.

The dosage and frequency of administration will be determined by the study protocol, and participants will be instructed on how to take the medication as part of their daily routine.

4 ongoing monitoring

Throughout the study, participants will undergo regular monitoring to assess their health and the effectiveness of the treatment. This includes scheduled visits to the study center for evaluations and tests.

Participants will be monitored for any side effects or adverse reactions to the medication, and their progress will be documented by the study team.

5 completion of the study

At the end of the study period, participants will undergo a final assessment to evaluate the outcomes of the treatment. This includes a review of their medical condition and any changes observed during the study.

Participants will be informed of the study results and any further steps or follow-up care that may be necessary.

Who Can Join the Study?

  • The participant must have a diagnosis of liver cirrhosis with medically controlled ascites for more than 30 days. Ascites is a condition where fluid builds up in the abdomen. It should be controlled by diet or medication and should not require frequent medical procedures to remove the fluid.
  • The participant must have a Conn (West Haven Criteria [WHC]) score of less than 2. This is a scale used to measure the severity of confusion or altered mental state due to liver disease.
  • The participant must have a Mini-Mental State Examination (MMSE) score greater than 24 at screening. This is a test that checks mental functions like memory and understanding.
  • The participant must be between 18 and 85 years old.
  • Females who can have children must have a negative pregnancy test at the start of the study. All participants must agree to use highly effective birth control methods during the study.
  • The participant must be able to read, understand, and sign a consent form on their own, which is approved by an ethics committee. This form explains the study and the participant’s rights.

Who Cannot Join the Study?

  • Patients who have a different condition than Hepatic Encephalopathy (OHE) cannot participate. Hepatic Encephalopathy is a condition that affects the brain and is caused by liver problems.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not willing to follow the study procedures or take the study medication as directed cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate in this study.
  • Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
  • Patients who have any other serious medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have a history of substance abuse or alcohol dependency cannot participate.
  • Patients who have had a major surgery recently or are planning to have surgery during the study period cannot participate.
  • Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Sliven Bulgaria
University Of Pecs Pecs Hungary
IRCCS Humanitas Research Hospital Rozzano Italy
Centre Hospitalier Universitaire De Lille Lille France
Medizinische Hochschule Hannover Hanover Germany
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Ziekenhuis Oost Limburg Genk Belgium
EMC Instytut Medyczny S.A. Wroclaw Poland
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
ID Clinic Myslowice Poland
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Klinikum Chemnitz gGmbH Chemnitz Germany
Universita’ Politecnica Delle Marche Ancona Italy
Hospital General Universitario De Valencia Valencia Spain
Assistance Publique Hopitaux De Paris Paris France
Semmelweis University Budapest Hungary
Charite Research Organisation GmbH Berlin Germany
Deutsches Herzzentrum Berlin Berlin Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
University Childrens Hospital Queen Fabiola Brussels Belgium
Az Maria Middelares Gent Gent Belgium
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Medical Center Teodora EOOD Ruse Bulgaria
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Hopital Nord Franche-Comte Belfort France
Hospital Paul Brousse Villejuif France
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Hôpital Pontchaillou-CHU Rennes Rennes France
Assistance Publique Hopitaux De Paris Creteil France
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Hospital Universitario Virgen De La Victoria Malaga Spain
Pyhn Tbkct Hjtwtldx Uqaupfrxvbhl Sabadell Spain
Cqnp Dc Nmgua Vandoeuvre Les Nancy France
Bbabw Hgkbmqsrznzg Cybolph Budapest Hungary
Nvnqboxyypvh Zsowlq Osdyyc Zpforhwmmy Tccdi Zjiogfz Ed Swj z ogzy Elblag Poland
Clcsfd Hcptgxgjcsp Eu Ulidflvbgfvpm Dv Lwkcfpl Limoges France
Aaqwkdiczi Pscqtptg Hiortofz Dv Pkhft Paris France
Ahvbdmpjwy Pkfwmvdf Hbzukahz Dq Mrpnpnkzr Marseille France
Bpysbqku Ufenglfdtm Hlusslas Cnihpt Besançon France
Gwzqrl Uyslrktxto Fyanminnf Frankfurt Germany
Arzhdpf Uugqs Sjklvrusy Lwimsv Dp Bqqjybq Bologna Italy
Hhnwekva De Ls Spmzp Cnkh I Suqz Pii Barcelona Spain
Ukqciegagx Ob Abgfoio Edegem Belgium
Ugiaymkzhe Mkqnfva Cugnwb Hoqloixfoutauqseu Hamburg Germany
Utwyeyolmiufcuxkgxsav Eadfd Adc Essen Germany
Cfeith Hzmjmujyfzv Rokecpep Dwwnmwyjdpgwzm Angers France
Esaaavm Mechelen Belgium
Cow Ctrfp Rzjlkyyzxzp Lyon France
Hadghads Vfuu dkdlkava Barcelona Spain
Hxuxrxn Hpzps Muvsan &ssgeeb 1 ryl Glfyled Epgmeb Creteil France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.08.2023
Bulgaria Bulgaria
Not recruiting
15.08.2023
France France
Not recruiting
15.08.2023
Germany Germany
Not recruiting
15.08.2023
Hungary Hungary
Not recruiting
15.08.2023
Italy Italy
Not recruiting
15.08.2023
Poland Poland
Not recruiting
15.08.2023
Spain Spain
Not recruiting
15.08.2023

Trial locations

Investigated drugs:

Rifaximin is a medication used in this clinical trial. It is designed to help people with liver disease, specifically cirrhosis, by delaying the worsening of a condition called hepatic encephalopathy. This condition can cause confusion and other mental changes due to liver problems. Rifaximin works by reducing the number of bacteria in the gut that produce toxins, which can affect the brain when the liver is not functioning properly. In this study, the medication is being tested to see if it can help prevent hospitalizations related to this condition.

Investigated diseases:

Hepatic Encephalopathy – Hepatic Encephalopathy is a condition that affects the brain due to liver dysfunction. It occurs when the liver is unable to remove toxins from the blood, leading to a buildup that can affect brain function. Symptoms can range from mild confusion and forgetfulness to severe mental changes and even coma. The progression of the disease can vary, with episodes of worsening symptoms followed by periods of improvement. Factors such as infections, dehydration, or certain medications can trigger or worsen the condition. Over time, repeated episodes can lead to more persistent cognitive impairments.

Trial ID:
2022-502899-23-00
Protocol code:
RNLC3132
NCT ID:
NCT05297448
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of VS-01 with different treatment times compared to standard care alone in patients with overt hepatic encephalopathy and liver cirrhosis complications

    Not recruiting

    2 1 1
    Investigated diseases:
    Belgium France Germany Spain