Can a Two-Drug combo calm immune overreaction and help the liver regrow in severe alcoholic hepatitis?
NCT ID NCT06890039
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether adding TAK-242 and G-CSF to standard care is safe and more effective than standard care alone for people with severe alcoholic hepatitis and acute-on-chronic liver failure (ACLF). TAK-242 aims to block an immune system overreaction, while G-CSF encourages liver cells to grow. The trial enrolls 78 adults with steroid-resistant or steroid-contraindicated severe alcoholic hepatitis and grade 1 to 3 ACLF. Participants receive either the drug combination or a placebo, and researchers track side effects and changes in organ failure scores over 14 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TAK-242, an experimental drug that blocks an immune overreaction, given with G-CSF (filgrastim), a drug that stimulates liver cell growth
- What this could lead to
- If it works, this combination could offer a new way to treat severe alcoholic hepatitis with acute-on-chronic liver failure, a condition with high short-term mortality.
- What could go wrong
- This is an early phase 2 trial with 78 participants, so safety and effectiveness are still uncertain. The combination may not improve outcomes or could cause side effects that outweigh any benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients accepted for inclusion into the study must meet all of the following criteria: 1. Male and female subjects ≥18 of age and ≤75 years of age 2. Compliance with acceptable contraceptive methods. 3. With a diagnosis of severe alcoholic hepatitis that is resistant to steroid therapy as defined by a Lille score of \>0.45 and/or in whom steroids are contraindicated. 4. Eligible subjects will have Grade 1-3 ACLF with a maximum of three organ failures using the CLIF-C OF score AND the CLIF-C ACLF-CRP score of \>35 and \<60. Exclusion Criteria: * Patients with any of the following criteria are to be excluded: * Refusal to give informed consent * Mechanical ventilation due to respiratory failure and/or need for renal replacement therapy and or requiring inotropes for circulatory support with a noradrenaline requirement of \>0.5ug/kg/min to maintain mean arterial pressure \> 70mmHg * Subject has received any investigational drug within 30 days of randomization * Subject has any of the following conditions: * history of liver transplantation * postoperative decompensation after partial hepatectomy * liver failure without underlying chronic liver injury * Any untreated infections (\<48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV. * Chronic or pre-existing kidney failure, survival prognosis of \<6 months due to severe co-morbid conditions that might confound study results or compromise subject safety * Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anemia * Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency. * Active malignancy, premalignant hematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukemia) or multiorgan failure (≥ 4 organ failures). * Pregnancy or nursing women * Allergy to eggs
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Royal Free Hospital
RECRUITINGLondon, Greater London, NW3 2QG, United Kingdom
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Other studies related to the condition(s) this trial covers.
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- Experimental injection aims to combat Life-Threatening liver failure
- Blood transfusion strategy could be refined for liver patients