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Study on the Safety and Effects of Resatorvid and Filgrastim for Patients with Severe Alcoholic Hepatitis and Acute-on-Chronic Liver Failure

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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 two serious liver conditions: severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF). Severe alcoholic hepatitis is a condition caused by excessive alcohol consumption, leading to liver inflammation. Acute-on-chronic liver failure is a syndrome that occurs in patients with chronic liver disease, characterized by sudden liver failure and potentially affecting other organs like the kidneys and brain. The study will test the safety of a new treatment combining two medications: Resatorvid (TAK-242), which is a selective inhibitor of TLR4-mediated signaling, and Granulocyte Colony-Stimulating Factor (G-CSF), a substance that helps the body produce more white blood cells. A placebo will also be used for comparison.

The purpose of this study is to evaluate the safety of the combination treatment in patients with these liver conditions. Participants will receive either the combination of Resatorvid and G-CSF, Resatorvid alone, or a placebo. The treatment will be administered over a period of up to 10 days. The study will monitor the participants for any side effects and assess the impact of the treatment on liver function and overall health. The trial aims to understand how the treatment affects inflammation, liver function, and the body's ability to recover from liver failure.

Throughout the study, researchers will collect data on various health markers, including inflammation and liver function, to determine the effectiveness of the treatment. The study will also look at the quality of life of participants and the number of days they spend in intensive care. The ultimate goal is to find a safe and effective treatment option for patients suffering from severe alcoholic hepatitis and acute-on-chronic liver failure.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and current health status.

    The assessment will ensure that the criteria for participation are met, such as age and specific health conditions related to severe alcoholic hepatitis and acute-on-chronic liver failure.

  2. Step 2

    Randomization

    Participants will be randomly assigned to one of the study groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the study medication or a placebo.

  3. Step 3

    Medication administration

    Participants will receive either Resatorvid (TAK-242) or a placebo as a concentrate for solution for infusion. This will be administered according to the study schedule.

    Additionally, participants may receive Neupogen (filgrastim) or a matching placebo via subcutaneous injection. This will be administered six times: once daily from days 1 to 5, and once more on day 8.

  4. Step 4

    Monitoring and assessments

    Regular monitoring will occur throughout the study to assess health status and any changes. This includes checking vital signs, organ function, and other health indicators.

    Participants will be evaluated for any side effects or adverse reactions to the medications.

  5. Step 5

    Follow-up visits

    Follow-up visits will be scheduled to continue monitoring health and gather data on the effectiveness and safety of the treatment.

    These visits will include assessments of quality of life and any changes in health status.

  6. Step 6

    Study completion

    Upon completion of the study period, a final assessment will be conducted to evaluate overall health and any long-term effects of the treatment.

    Participants will receive information about the study results and any further steps if necessary.

Who can join the trial?

4 criteria

  • Participants must be between 18 and 75 years old.
  • Participants must agree to use acceptable contraceptive methods to prevent pregnancy during the study.
  • Participants must have a diagnosis of severe alcoholic hepatitis that does not respond to steroid treatment, or they cannot take steroids for medical reasons. This is determined by a Lille score greater than 0.45. The Lille score is a measure used to predict the response to steroid treatment in liver disease.
  • Participants must have Grade 1 to 3 ACLF (Acute-on-Chronic Liver Failure) with no more than three organ failures. This is assessed using the CLIF-C OF score and the CLIF-C ACLF-CRP score, which should be greater than 35 and less than 60. These scores help to evaluate the severity of liver failure and the risk of complications.

Who cannot join the trial?

3 criteria

  • Patients with more than three organ failures cannot participate. Organ failures can include problems with the liver, kidneys, brain, blood clotting, breathing, or heart.
  • Patients with a **CLIF-C ACLF-CRP score** outside the range of 35 to 60 are not eligible. This score is a measure used to assess the severity of liver disease.
  • Patients with a **Grade 1 ACLF** who have a risk of mortality greater than 15% at 28 days are excluded. ACLF stands for Acute-on-Chronic Liver Failure, a condition affecting the liver.
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Investigated drugs

  • TAK-242

    is a medication being studied for its potential to help people with severe alcoholic hepatitis and acute-on-chronic liver failure. It works by blocking certain signals in the body that can cause inflammation. Inflammation is a part of the body's response to injury or illness, but too much inflammation can be harmful, especially in the liver. By reducing this inflammation, TAK-242 may help improve liver function and overall health in patients with these conditions.

  • Granulocyte Colony-Stimulating Factor (G-CSF)

    is a therapy that helps the body produce more white blood cells. White blood cells are important for fighting infections and keeping the immune system strong. In this trial, G-CSF is used to support patients with severe liver conditions, as they may have weakened immune systems. By boosting the production of white blood cells, G-CSF aims to help these patients better fight infections and improve their overall health.

What is already known about the treatment

  • TAK-242

    TAK-242 is administered orally and is currently being studied in clinical trials to assess its safety and effectiveness. It is being investigated for its potential use in treating severe alcoholic hepatitis and acute-on-chronic liver failure, conditions that involve severe liver damage and failure. TAK-242 works by blocking a specific pathway in the immune system that can cause inflammation, which is a key factor in liver damage. It is classified as an anti-inflammatory agent.

  • Granulocyte Colony-Stimulating Factor (G-CSF)

    G-CSF is typically administered through injection and is also being studied in clinical trials for its safety and effectiveness. It is used to help treat severe alcoholic hepatitis and acute-on-chronic liver failure by stimulating the production of white blood cells, which can help the body fight infections and support liver recovery. G-CSF works by encouraging the bone marrow to produce more white blood cells, enhancing the immune response. It is classified as a hematopoietic growth factor.

Investigated diseases

Acute-on-Chronic Liver Failure (ACLF) – Acute-on-Chronic Liver Failure is a syndrome that occurs in individuals with chronic liver disease, which may or may not include previously diagnosed cirrhosis. It is characterized by a sudden worsening of liver function, known as acute hepatic decompensation, leading to liver failure. This condition manifests through symptoms such as jaundice and an increased international normalized ratio (INR). ACLF often involves the failure of one or more organs outside the liver, such as the kidneys, brain, blood coagulation system, respiratory system, or cardiovascular system. The severity of ACLF is graded, with Grade 1 involving a risk of mortality, although this description focuses on the progression rather than outcomes. The condition is associated with systemic inflammation and requires careful monitoring of organ function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501026-37-00Protocol codeG-TAK-ES-01Estimated enrolment78 patientsSponsorAlpha Bioresearch S.L.

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