Can a Two-Drug combo calm immune overreaction and help the liver regrow in severe alcoholic hepatitis?

NCT ID NCT06890039

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Royal Free Hospital

    RECRUITING

    London, Greater London, NW3 2QG, United Kingdom

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