- A-TANGO Phase 2 Study — Recruiting • Phase II • Cardiology / Cardiovascular • NCT06890039.
- What is being tested: A combination therapy of TAK-242 (a TLR4 antagonist) plus G-CSF (granulocyte-colony stimulating factor) added to standard ACLF treatment, compared to standard therapy alone, to evaluate efficacy and safety.
- Patient eligibility overview: The study enrolls patients with acute-on-chronic liver failure who meet diagnostic criteria; specific inclusion/exclusion criteria would determine suitability based on disease severity, liver function parameters, and comorbidities.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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 therapy for ACLF treatment and is safe. Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis)…
- : * 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 .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 (
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.