A-TANGO Phase 2 Study

Launched by YAQRIT LTD · Mar 20, 2025

Keywords

ClinConnect Summary

The A-TANGO Phase 2 Study is a clinical trial exploring whether a new combination of two drugs, TAK-242 and G-CSF, works better and is safe when added to standard treatment for patients with acute-on-chronic liver failure (ACLF) caused by alcohol-related liver disease. ACLF is a serious condition where the liver suddenly stops working properly, which can lead to complications like jaundice (yellowing of the skin or eyes) and fluid buildup in the abdomen. The goal is to see if these new medications can help improve liver function by calming an overactive immune response and encouraging liver cell growth.

To be eligible for this study, participants must be between 18 and 75 years old and have severe alcoholic hepatitis that hasn't improved with steroid treatment. They should also have a specific level of liver failure and complications as defined by certain medical criteria. During the trial, participants will receive the investigational drugs along with standard care and will be monitored closely for safety and effectiveness. It's important to know that the study is not yet recruiting participants, but it aims to help those facing serious liver issues find better treatment options.

Gender

ALL

Eligibility criteria

• 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