TAK-242 and G-CSF in ACLF: a new treatment approach for adults with acute-on-chronic liver failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study evaluating TAK-242 alone or with G-CSF in addition to standard therapy for acute-on-chronic liver failure. Seventy-eight adults hospitalized with ACLF and alcoholic hepatitis are randomized in a 1:1:1 ratio to: standard of care with placebo, TAK-242 for 10 days with placebo, or TAK-242 for 10 days plus daily G-CSF injections. Participants are followed on Days 14, 28, and 84, with total participation around 86 days per subject and overall study duration about 42 months. Primary aims include safety of TAK-242 alone or with G-CSF and effects on ACLF disease severity; the study is designed to determine whether the combination can improve clinical outcomes compared with standard care. The trial uses three arms and includes hospitalized patients meeting specific severity criteria, with careful monitoring in addition to standard therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Free Hospital
  London, Greater London, United Kingdom Recruiting

Study contacts

• Study coordinator: Monica Razdan
• Email: monica.razdan@klinera.com
• Phone: +917045561443

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Prolonged steroids with NAC for severe alcoholic hepatitis

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• AS1501 in ACLF: a two-stage dose study in adults with acute-on-chronic liver failure

  This Phase II study tests AS1501 given by injection in adults with early ACLF to see if it’s safe and tolerable and to guide dosing.

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• Using different ROTEM cut-offs to guide blood transfusions before procedures in cirrhosis and ACLF

  This will test whether using relaxed ROTEM cut-offs to decide on blood transfusions reduces the number of transfusions without raising bleeding risk for people with cirrhosis or ACLF and severe coagulopathy who need invasive procedures.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi, National Capital Territory of Delhi · NCT06831565

• Ceftazidime-avibactam vs high-dose meropenem for ACLF patients with hospital-acquired infections

  This trial tests whether ceftazidime-avibactam can better treat infections in ACLF patients than high-dose meropenem given in extended infusions, aiming to spare carbapenems if possible.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.