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

2 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Deutsches Herzzentrum Berlin Berlin Germany
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. Vila Real Portugal
Universitaetsklinikum Leipzig AöR Leipzig Germany
Cwyxva Hmzdcvvgry Uzdddfqlroxpf Ds Peqgv Egpazn Porto Portugal
Hykbdsla Dy Lt Skrey Cpwe I Stkf Pce Barcelona Spain

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

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
17.04.2023
Portugal Portugal
Not yet recruiting
17.04.2023
Spain Spain
Not yet recruiting
17.04.2023

Trial locations

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.

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 ID:
2022-501026-37-00
Protocol code:
G-TAK-ES-01
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of N-acetylcysteine and prednisolone combination versus extended prednisolone treatment in patients with severe alcoholic hepatitis

    Recruiting

    3 1 1
    France
  • Study on the Effects of Alpha-1 Antitrypsin and Prednisolone in Patients with Severe Alcohol-Related Hepatitis

    Recruiting

    2 1 1 1
    Investigated diseases:
    Austria