Status:
NOT_YET_RECRUITING
A-TANGO Phase 2 Study
Lead Sponsor:
Yaqrit Ltd
Collaborating Sponsors:
European Foundation for Study of Chronic Liver Failure
University College, London
Conditions:
Acute-On-Chronic Liver Failure
Alcoholic Hepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard...
Detailed Description
The purpose of this Phase 2 clinical trial is to investigate * the safety of TAK-242 alone or in combination with G-CSF (G-TAK) in patients with sAH and ACLF. * the effect of TAK-242 alone or in comb...
Eligibility Criteria
Inclusion
- Patients accepted for inclusion into the study must meet all of the following criteria:
- Male and female subjects ≥18 of age and ≤75 years of age
- Compliance with acceptable contraceptive methods.
- 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.
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06890039
Start Date
September 1 2025
End Date
December 31 2026
Last Update
July 29 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.