Clinical Trials for Hepatic Encephalopathy
Currently, there are 2 ongoing clinical trials for hepatic encephalopathy, a brain condition that occurs when the liver cannot effectively remove toxins from the blood. These studies are testing new treatments across multiple European countries, including Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, and Spain.
Clinical trial locations
- Belgium
- Bulgaria
- France
- Germany
- Hungary
- Italy
- Poland
- Spain
Study of VS-01 with different treatment times compared to standard care alone in patients with overt hepatic encephalopathy and liver cirrhosis complications
This study focuses on testing a new investigational medicine called VS-01 in patients with overt hepatic encephalopathy, a condition where brain function is affected due to advanced liver disease. The medicine is given as a suspension directly into the abdominal cavity in addition to regular standard treatment.
Main goal: The purpose of this research is to determine if VS-01 can help treat overt hepatic encephalopathy when given once daily for up to 4 days. The study will compare two different treatment durations (3 hours and 4 hours) of VS-01 combined with standard care against standard care alone. During the study, doctors will monitor how quickly patients’ symptoms improve and track any changes in blood and abdominal fluid composition to ensure the treatment is safe.
Who can participate:
- You must have liver cirrhosis confirmed by clinical tests, imaging, or tissue examination, along with brain dysfunction caused by liver disease
- You must have ascites (fluid buildup in the abdomen) that requires drainage through a medical procedure
- Your blood ammonia levels must be higher than normal
- Your dry body weight must be between 40 kg and 140 kg (88-308 pounds)
- You must be between 18 and 79 years old
- You must be willing and able to provide written consent to participate
Who cannot participate:
- Patients with severe liver failure (beyond grade 1 acute-on chronic liver failure)
- Patients below 18 years of age
- Patients with known allergies to the study medication
- Pregnant or breastfeeding women
- Patients with severe kidney problems requiring dialysis
- Patients with active gastrointestinal bleeding
- Patients with unstable vital signs
- Patients currently participating in other clinical trials
- Patients with active infections or sepsis
- Patients with history of abdominal surgery in the past 3 months
- Patients with portal vein thrombosis (blood clot in the main blood vessel of the liver)
Investigational drug: VS-01 is a medication administered directly into the abdominal cavity in addition to standard care treatment. It is given once daily and remains in the abdominal cavity for several hours. The medication contains citric acid as its main component. This is a novel therapeutic approach being tested as an add-on therapy to current standard treatments.
Study on Rifaximin for Delaying Hepatic Encephalopathy in Cirrhosis Patients
This clinical 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 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.
Main goal: 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. 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. 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.
Who can participate:
- You must have a diagnosis of liver cirrhosis with medically controlled ascites for more than 30 days. The fluid should be controlled by diet or medication and should not require frequent medical procedures to remove it
- You must have a Conn (West Haven Criteria) score of less than 2, which measures the severity of confusion or altered mental state due to liver disease
- You must have a Mini-Mental State Examination score greater than 24 at screening, which checks mental functions like memory and understanding
- You 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 and agree to use highly effective birth control methods during the study
- You must be able to read, understand, and sign a consent form on your own
Who cannot participate:
- Patients who have a different condition than hepatic encephalopathy
- Patients who are not within the specified age range
- Patients who are not willing to follow the study procedures or take the study medication as directed
- Patients currently participating in another clinical trial
- Patients with a history of allergic reactions to the study medication or similar medications
- Patients with any other serious medical conditions that might interfere with the study
- Patients who are pregnant or breastfeeding
- Patients with a history of substance abuse or alcohol dependency
- Patients who have had a major surgery recently or are planning to have surgery during the study period
- Patients who have any condition that makes them unsuitable for the study in the opinion of the study doctor
Investigational drug: Rifaximin is an antibiotic that specifically targets the gut. It is administered orally in tablet form and works by reducing the number of bacteria in the gut that produce toxins. These toxins can affect the brain when the liver is not functioning properly. The medication is being tested to see if it can help prevent hospitalizations related to this condition.
Summary
Both ongoing clinical trials for hepatic encephalopathy are being conducted across multiple European countries, with France, Germany, Belgium, and Spain hosting both studies. Poland, Italy, Hungary, and Bulgaria are participating in the Rifaximin study only.
The trials represent two different approaches to managing this liver-related brain condition. The VS-01 study focuses on acute treatment of overt hepatic encephalopathy using a novel intraperitoneal therapy, while the Rifaximin study aims to prevent the worsening of symptoms and reduce hospitalizations in patients with more stable, controlled cirrhosis.
Both studies require participants to have confirmed liver cirrhosis, but they target different stages and severity of the condition. The VS-01 trial is shorter in duration (up to 4 days of treatment) and focuses on patients with acute complications, while the Rifaximin study appears to be longer-term and focuses on prevention. Both trials exclude pregnant women, patients with severe additional medical conditions, and those currently participating in other clinical trials.
