A-TANGO Phase 2 Study

Launched by YAQRIT LTD · Mar 20, 2025

Keywords

ClinConnect Summary

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 combination with G-CSF (G-TAK) on the disease severity of ACLF.

Study design:

Multi-center, randomized, double-blind, placebo-controlled trial. Study drug will be administered while subjects are hospitalized. Patients will have been hospitalized for their underlying disease.

78 patients to be randomized (1:1:1) to one of the following three arms:

* Standard of care (SOC) plus placebo for TAK-24...

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