Ongoing Clinical Trials for Acute on Chronic Liver Failure
There are currently 4 ongoing clinical trials investigating new treatments for acute on chronic liver failure (ACLF), a serious condition where sudden liver failure occurs in people with existing chronic liver disease. These trials are testing various investigational therapies including cell-based treatments, anti-inflammatory medications, and novel compounds designed to reduce harmful substances in the body. The studies are being conducted across multiple European countries including Spain, Germany, Portugal, Belgium, France, Italy, and Hungary.
Clinical trial locations
- Belgium
- France
- Germany
- Study on the Safety and Effects of Resatorvid and Filgrastim for Patients with Severe Alcoholic Hepatitis and Acute-on-Chronic Liver Failure
- Study of VS-01 with different treatment times compared to standard care alone in patients with overt hepatic encephalopathy and liver cirrhosis complications
- Study on the Effects of VS-01 for Adults with Acute-on-Chronic Liver Failure and Ascites
- Hungary
- Italy
- Portugal
- Spain
- Study on the Safety and Effects of Resatorvid and Filgrastim for Patients with Severe Alcoholic Hepatitis and Acute-on-Chronic Liver Failure
- Study of VS-01 with different treatment times compared to standard care alone in patients with overt hepatic encephalopathy and liver cirrhosis complications
- Study on the Effects of VS-01 for Adults with Acute-on-Chronic Liver Failure and Ascites
Study on the Safety and Effects of Resatorvid and Filgrastim for Patients with Severe Alcoholic Hepatitis and Acute-on-Chronic Liver Failure
This trial is testing a combination treatment for patients with severe alcoholic hepatitis and acute-on-chronic liver failure. The study examines whether combining two medications can help reduce inflammation and improve liver function in these patients.
Who can participate:
- Adults between 18 and 75 years old
- Patients with severe alcoholic hepatitis that does not respond to steroid treatment (shown by a Lille score greater than 0.45) or those who cannot take steroids for medical reasons
- Patients with Grade 1 to 3 ACLF with no more than three organ failures, as measured by specific scoring systems
- Must agree to use acceptable contraceptive methods during the study
Who cannot participate:
- Patients with more than three organ failures affecting the liver, kidneys, brain, blood clotting, breathing, or heart
- Patients with a CLIF-C ACLF-CRP score outside the range of 35 to 60
- Patients with Grade 1 ACLF who have a risk of mortality greater than 15% at 28 days
What the study involves:
The trial tests two investigational drugs: Resatorvid (TAK-242), which works by blocking signals in the body that cause harmful inflammation, and Granulocyte Colony-Stimulating Factor (G-CSF), which helps the body produce more white blood cells to fight infections. Participants will receive either the combination of both medications, Resatorvid alone, or a placebo. The treatment is administered over a period of up to 10 days, during which researchers will monitor inflammation levels, liver function, and overall health status.
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 patients with hepatic encephalopathy, a brain condition caused by advanced liver disease, who also have liver cirrhosis with sudden worsening of symptoms. The trial tests whether an investigational medicine called VS-01 can help improve brain function when added to standard treatment.
Who can participate:
- Adults between 18 and 79 years old
- Patients with confirmed liver cirrhosis and hepatic encephalopathy
- Those with ascites (fluid buildup in the abdomen) requiring drainage
- Blood ammonia levels higher than normal
- Body weight between 40 kg and 140 kg (88-308 pounds)
- Able to provide written consent or have a legally authorized representative sign on their behalf
Who cannot participate:
- Patients with severe liver failure beyond grade 1
- Those below 18 years of age
- Patients with known allergies to the study medication
- Pregnant or breastfeeding women
- Patients with severe kidney problems requiring dialysis
- Those with active gastrointestinal bleeding
- Patients with unstable vital signs
- Those currently participating in other clinical trials
- Patients with active infections or sepsis
- Those who had abdominal surgery in the past 3 months
- Patients with portal vein thrombosis (blood clot in the main blood vessel of the liver)
What the study involves:
The trial tests VS-01, a medication containing citric acid that is given directly into the abdominal cavity once daily for up to 4 days. The study compares two different treatment durations (3 hours and 4 hours) of VS-01 combined with standard care against standard care alone. Researchers will monitor how quickly patients’ symptoms improve and collect blood and abdominal fluid samples to ensure the treatment is safe. The medication remains in the abdomen for either 3 or 4 hours, depending on the assigned treatment group.
Study on the Effects of VS-01 for Adults with Acute-on-Chronic Liver Failure and Ascites
This trial examines whether VS-01 can improve outcomes for patients with grades 1 and 2 ACLF who also have ascites. The study evaluates whether adding VS-01 to standard care can help reduce the harmful buildup of substances like ammonia in the body.
Who can participate:
- Adults between 18 and 79 years old
- Patients with liver cirrhosis diagnosed by standard medical methods
- Those with ACLF Grade 1 or 2 that started no more than 7 days before screening
- Patients with ascites requiring paracentesis (a procedure to remove fluid)
- Dry body weight (weight without extra fluid) between 40 kg and 140 kg
- Able to understand and sign consent, or have a legal representative sign following local laws
Who cannot participate:
- Patients with severe liver failure beyond grade 2
- Those with other serious organ failures besides the liver
- Patients with uncontrolled infections
- Pregnant or breastfeeding women
- Those with known allergies to the study medication or its ingredients
- Patients who participated in another clinical trial recently
- Those with mental health conditions that might affect their ability to follow study instructions
- Patients with substance abuse issues
- Those who have had a liver transplant
What the study involves:
Participants receive VS-01, administered directly into the abdominal cavity once daily for four days, in addition to their standard treatment. The study monitors patients’ CLIF-C ACLF score on Day 7, which measures the severity of liver failure. Secondary outcomes include survival rates at 28 and 90 days, changes in ACLF grade, transplant-free survival, and any side effects. The medication works by targeting and reducing the accumulation of harmful substances like ammonia, which can affect brain function.
Study on the Safety and Effectiveness of HepaStem for Patients with Acute on Chronic Liver Failure (ACLF)
This trial evaluates HepaStem, a cell therapy using Human Allogeneic Liver-Derived Progenitor Cells, for patients with ACLF. The study aims to determine whether this treatment can improve survival rates and liver function.
Who can participate:
- Adults between 18 and 75 years old
- Patients with an initial diagnosis of ACLF at the investigational site
- Those with ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition
- Patients with a total bilirubin level of 5 mg per dL or higher (bilirubin is a substance made by the liver, and high levels indicate liver problems)
- Able to read, understand, and give written informed consent (if the patient has hepatic encephalopathy and cannot fully understand, a legal representative must sign the consent form)
Who cannot participate:
- Patients not experiencing an acute worsening of their liver condition
- Those without pre-existing chronic liver disease
- Patients who do not have failures in other organs outside the liver
- Those not experiencing severe inflammation throughout the body
- Patients not at high risk of dying within 28 days
What the study involves:
The trial tests HepaStem, a cell therapy involving special cells infused into the body through a vein. Participants receive two infusions of these cells at a dose of 1.0 million cells per kilogram of body weight, with seven days between each infusion. The study is double-blinded, meaning neither patients nor doctors know who receives HepaStem or the placebo. The main goal is to assess survival rates 90 days after the first infusion. Researchers also monitor survival without needing a liver transplant, duration of hospital stays, infections, and changes in blood tests related to liver function. The therapy aims to improve liver function and increase survival chances by reducing inflammation and supporting liver health.
Summary
The four ongoing clinical trials for acute on chronic liver failure represent diverse therapeutic approaches being tested across Europe. Two of the trials focus on VS-01, a novel compound administered directly into the abdominal cavity, with one trial examining its effects on hepatic encephalopathy and another on ACLF grades 1 and 2. These trials are being conducted in multiple countries including Belgium, France, Germany, Spain, Italy, and Hungary.
Germany and Spain have the broadest participation, hosting three trials each. The investigational treatments being tested range from anti-inflammatory medications like Resatorvid combined with G-CSF, to cell-based therapies like HepaStem, to the novel VS-01 compound. Most trials focus on patients with ACLF grades 1 and 2, with treatment periods ranging from 4 to 10 days.
Common exclusion criteria across the studies include severe multi-organ failure, uncontrolled infections, pregnancy, and recent participation in other clinical trials. The trials employ various assessment methods, including CLIF-C ACLF scoring systems, survival rates at 28 and 90 days, and monitoring of liver function markers. These studies aim to address the urgent need for effective treatments for this life-threatening condition where current treatment options remain limited.
