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Citric Acid, Anhydrous Ph. Eur.

This article discusses the ongoing clinical trials investigating the use of Citric Acid, Anhydrous Ph. Eur., a component of the experimental drug VS-01, in treating acute-on-chronic liver failure (ACLF). The research focuses on patients with ACLF grades 1 and 2 who also experience ascites, a condition where fluid accumulates in the abdominal cavity. The trials aim to evaluate the efficacy, safety, and tolerability of VS-01 when administered alongside standard care, compared to standard care alone.

Table of Contents

What is VS-01?

VS-01 is a new medicinal product being studied for the treatment of a serious liver condition called acute-on-chronic liver failure (ACLF) in patients who also have ascites[1]. It is a suspension for infusion, which means it’s a liquid medication that is given through a special route in your body.

The active ingredient in VS-01 is citric acid, anhydrous. While citric acid is commonly known as a substance found in citrus fruits, in this medication it’s being used in a purified form for medical purposes[1].

What conditions does VS-01 treat?

VS-01 is designed to treat acute-on-chronic liver failure (ACLF). Let’s break down what this means:

  • Chronic liver failure: This is long-term liver damage, often due to conditions like cirrhosis.
  • Acute-on-chronic liver failure (ACLF): This occurs when a person with chronic liver disease experiences a sudden worsening of their condition. It can lead to the failure of multiple organs and is very serious[1].
  • Ascites: This is a buildup of fluid in the abdomen, which is common in people with severe liver disease[1].

ACLF is particularly dangerous, with a mortality rate of about 50%. It can cause problems with brain function (a condition called hepatic encephalopathy) and the buildup of toxic substances in the body[1].

How VS-01 works

While the exact mechanism isn’t fully explained in the trial information, VS-01 is administered intraperitoneally. This means it’s given directly into the abdominal cavity where the excess fluid (ascites) has accumulated[1].

The medication is given daily for 4 days, suggesting it may help to remove toxins or reduce inflammation in the abdominal area. This could potentially help improve liver function and reduce the severity of ACLF[1].

Clinical Trial Information

VS-01 is currently being studied in a Phase 2a clinical trial. This is an early stage of testing in humans to see if the medication is effective and safe. The study is described as a “proof of concept” trial, which means it’s designed to see if the treatment shows promise and should be studied further[1].

The trial is comparing VS-01 plus standard care to standard care alone. This helps researchers understand if VS-01 provides additional benefits beyond current treatments[1].

Who can participate in the VS-01 trial?

The trial is looking for adult patients (ages 18-79) who have:

  • Liver cirrhosis (scarring of the liver)
  • ACLF grade 1 or 2 (specific levels of liver failure)
  • Ascites that requires drainage
  • Developed ACLF within the last 7 days[1]

There are many other specific criteria for who can and cannot participate. Your doctor would need to review these in detail to determine if you might be eligible[1].

Potential Benefits and Risks

Potential benefits of VS-01, if proven effective, could include:

  • Improved liver function
  • Reduced severity of ACLF
  • Better survival rates for patients with this serious condition[1]

However, as with any experimental treatment, there may be risks and side effects that are not yet known. The trial is designed to carefully monitor patients for any adverse reactions[1].

It’s important to remember that VS-01 is still in the testing phase. More research is needed to determine its effectiveness and safety before it could become widely available as a treatment[1].

Aspect Details
Drug Name VS-01 (containing Citric Acid, Anhydrous Ph. Eur.)
Condition Studied Acute-on-chronic liver failure (ACLF) grades 1 and 2 with ascites
Trial Phase Phase 2a proof of concept study
Administration Method Intraperitoneal (i.p.) daily for 4 days
Primary Endpoint CLIF-C ACLF score at Day 7
Key Secondary Endpoints Mortality rates, time to ACLF resolution, transplant-free survival
Patient Population Adults 18-79 years with liver cirrhosis and ACLF grade 1 or 2
Study Duration 90 days (4-day treatment period + follow-up)
Comparison VS-01 + Standard of Care vs. Standard of Care alone

FAQ

  • What is acute-on-chronic liver failure (ACLF)? ACLF is a serious condition characterized by sudden worsening of liver function in patients with existing chronic liver disease. It involves both liver and other organ dysfunction, along with increased inflammation throughout the body. ACLF can lead to a buildup of toxins like ammonia, which may cause brain-related complications.
  • What is VS-01 and how is it administered in the trial? VS-01 is an experimental drug containing Citric Acid, Anhydrous Ph. Eur. In the trial, it is administered intraperitoneally (directly into the abdominal cavity) daily for 4 days, in addition to standard care. This is done through a special catheter, followed by a washing step.
  • Who is eligible to participate in this clinical trial? The trial is open to adults aged 18-79 with liver cirrhosis and ACLF grade 1 or 2, who also have ascites requiring paracentesis. Participants must have developed ACLF within the last 7 days and weigh between 40-140 kg. Certain conditions, such as acute liver failure or need for kidney replacement therapy, may exclude participation.
  • What are the main goals of this clinical trial? The primary goal is to evaluate how effective VS-01 is in improving the CLIF-C ACLF score (a measure of liver failure severity) after 7 days. Secondary goals include assessing mortality rates, time to recovery from ACLF, and overall safety and tolerability of VS-01 in patients with ACLF.
  • How long does the trial last and what happens after the treatment period? The trial includes a 4-day treatment period followed by a follow-up period lasting until day 90. After the treatment period, all patients continue to receive standard care as determined by their doctor. This allows researchers to assess both short-term and longer-term effects of the treatment.

Ongoing Clinical Trials on Citric Acid, Anhydrous Ph. Eur.

  • 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:
    Investigated drugs:
    Belgium France Germany Spain

  • Study on the Effects of VS-01 for Adults with Acute-on-Chronic Liver Failure and Ascites

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy Spain

Glossary

  • Acute-on-chronic liver failure (ACLF): A severe condition where liver function suddenly worsens in patients with existing chronic liver disease, often leading to failure of multiple organs and high mortality rates.
  • Ascites: An accumulation of fluid in the abdominal cavity, often seen in patients with liver disease.
  • Cirrhosis: Advanced scarring of the liver caused by long-term liver damage, which can lead to liver failure.
  • Hepatic Encephalopathy (HE): A decline in brain function that occurs when the liver is unable to remove toxins from the blood effectively.
  • Paracentesis: A procedure to remove excess fluid from the abdominal cavity.
  • Intraperitoneal (i.p.) administration: A method of delivering medication directly into the abdominal cavity.
  • Standard of Care (SOC): The currently accepted treatment methods used for a specific condition.
  • CLIF-C ACLF score: A scoring system used to assess the severity of acute-on-chronic liver failure.
  • Hyperammonemia: An elevated level of ammonia in the blood, which can be toxic to the brain.
  • Transplant-free survival: The length of time patients live without needing a liver transplant.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-vs-01-for-adults-with-acute-on-chronic-liver-failure-and-ascites/