[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yaqrit Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100619642","phase-3-a-novel-extracorporeal-liver-support-therapy-in-alcf-and-to-evaluate-the-efficacy-of-dialive-20-a-liver-dialysis-device-100619642",false,"NCT07347275","A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.","A Multi-Centre, Randomised, Controlled Trial to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device, for the Treatment of Acute-on-Chronic Liver Failure (ACLF) A-TANGO Grade 2-4 Compared to Standard of Care (SoC)","Inclusion Criteria:\n\n* Adults aged 18-70 years, with a diagnosis of ACLF grade 2-4 (according to A-TANGO ACLF criteria, APPENDIX 1)\n* ACLF non-responsive to SoC for up to 48 hours prior to developing grade 2-4 ACLF.\n* Inclusion within 10 days from the onset of A-TANGO ACLF grade ≥ 2.\n\nExclusion Criteria:\n\n* A-TANGO ACLF grade ≥2 for more than 10 days prior to inclusion\n* Pregnancy\n* Co-infection with HIV and AIDS defining illness i.e. CD4+ T-cell count below 200 cells\u002FµL, a CD4+ T-cell percentage of total lymphocytes of less than 15%, or one of the defining illnesses such as PCP, Kaposi's sarcoma, CMV, Candidiasis etc.\n* Bacterial infection or sepsis unresponsive to treatment with antimicrobials for 48 hours indicated by (a) persistent pyrexia (b) rising white cell count, creactive protein and lactate (c) persistently positive cultures for bacteria or fungi and\u002For (d) worsening clinical state indicated by escalating requirement for fluid resuscitation, increasing vasopressors requirements or increasing organ support.\n* Invasive fungal infection (clinical or radiological evidence, not solely biomarker positivity such as BDG or galactomannan)\n* Acute or sub-acute liver failure in the absence of cirrhosis\n* Post-hepatectomy liver failure or primary non-function following transplantation\n* Previous liver transplant\n* Severe thrombocytopaenia (absolute platelet count \\\u003C20,000\u002Fmm3 at screening) or evidence of rapid decline in platelet count (\\> 50% reduction within the preceding 24 hrs)\n* INR \\>3.0, unless sustained correction for \\>24 hours following FFP\u002FPCC treatment\n* Severe disseminated intravascular coagulopathy (DIC)\n* Persistent haemodynamic instability as defined by:\n\n  (i) Norepinephrine(NE) dose \\>0.5µg\u002Fkg\u002Fmin, or, (ii) If a second pressor is used, a composite Norepinephrine equivalence index (NEEI) of dose \\>0.5µg\u002Fkg\u002Fmin (iii) Arterial lactate level \\>4mmol\u002FL despite 24 hours of adequate fluid resuscitation and pressor therapy\n* Severe respiratory failure: PaO2\u002FFiO2 (P\u002FF) ≤ 200 mmHg or 27kPa\n* Established on renal replacement therapy for longer than 24 hours prior to inclusion\n* A-TANGO WCC ACLF score \\>64 (APPENDIX 1)\n* Significant and\u002For uncontrolled bleeding (participants can be enrolled 48 hours after bleeding is controlled)\n* Active or prior history of non hepatic malignancy unless adequately treated or in complete remission for five or more years\n* HCC outside of Milan criteria.\n* Acute, extensive, portal vein thrombosis extending to and occluding superior mesenteric vein\n* Major systemic illness, aside from liver disease, that in the opinion of the investigator would preclude the participant from participating in the study (e.g. coronary artery disease, cerebrovascular disease, chronic pulmonary disease, chronic kidney disease, serious psychiatric disease)\n* Pre-existing chronic kidney disease (CKD) defined as eGFR (estimated glomerular filtration rate) \\\u003C30 mL\u002Fmin for 3 months or longer prior to screening\n* Severe frailty (Clinical Frailty Scale, CFS\\>5)\n* Severe malnourishment (BMI\\\u003C18)\n* Participants not considered appropriate for full active treatment including organ support\n* Participants who have a \"do not attempt cardio-pulmonary resuscitation\" order in place\n* Any participant who has received an investigational drug or device within 30 days, or who is scheduled to receive another investigational drug or device during the course of the study (concomitant observational studies are allowed)\n* Uncontrolled seizures\n* Evidence of new intracranial pathology such as cerebral hemorrhage or infarction.\n* Participants diagnosed with Creutzfeldt-Jakob disease.\n* Participants unable to consent for themselves, unless a legal representative\u002Fconsultee is appointed and approved as dictated by local and national legislation.\n* Known allergy to heparin, or type II thrombocytopaenia caused by heparin (HIT syndrome type II).\n* In the opinion of the investigator, recruitment to the the study would be unsafe for the participant.","ALL","18 Years","70 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is intended to demonstrate the efficacy and safety of the DIALIVE Liver Dialysis Device when incorporated into the standard management plan for participants with A-TANGO ACLF grade 2-4.\n\nA total of 72 evaluable participants, aged 18-70, will be enrolled in up to 12 clinical centres in the United Kingdom. Participants must have a history of liver cirrhosis and a deterioration within four weeks due to a precipitating event, leading to A-TANGO ACLF grade 2-4. Multicenter, individually randomised, controlled, open-label, parallel group trial using double-arm design. The control group will receive SoC for participants with ACLF. The DIALIVE 2.0 treatment group will receive SoC with the addition of up to 7 (seven) daily DIALIVE 2.0 treatment sessions within the 10-day treatment window. Seventy-two participants with ACLF (60% A-TANGO ACLF grade 2 at randomisation, and 40% A-TANGO ACLF grade 3 \\& 4 at randomisation) will be randomised 1:1 to receive either SoC or SoC + DIALIVE 2.0. This allows for 5% loss due to drop-out, and 5% censoring due to liver transplantation within 28 days. All randomised participants will be included in the intention to treat (ITT) analysis while all participants that receive at least one treatment cycle will be used for the safety population. For each participant, the study duration will be up to 105 days (screening: 5 days; treatment up to 10 days; follow up 90 days).\n\nThe total study duration is estimated to be approximately 18 months from screening of first participant until study completion of the last participant.",[27,28],"Acute-on-Chronic Liver Failure (ACLF)","Liver Cirrhosis","NOT_YET_RECRUITING","2026-04-08",{"date":32,"type":33},"2026-04-14","ACTUAL",{"date":35,"type":21},"2026-05",{"date":37,"type":21},"2027-05",{"name":39,"class":40},"Yaqrit Ltd","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100584492","phase-2-a-tango-phase-2-study-100584492","NCT06890039","A-TANGO Phase 2 Study","Phase II, Double-blind, Randomized, Placebo-controlled, Multicentre Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TAK-242 and (G-CSF) in Subjects With (sAH) and (ACLF)","A-TANGO","Inclusion Criteria:\n\n* Patients accepted for inclusion into the study must meet all of the following criteria:\n\n  1. Male and female subjects ≥18 of age and ≤75 years of age\n  2. Compliance with acceptable contraceptive methods.\n  3. With a diagnosis of severe alcoholic hepatitis that is resistant to steroid therapy as defined by a Lille score of \\>0.45 and\u002For in whom steroids are contraindicated.\n  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 \\\u003C60.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria are to be excluded:\n\n  * Refusal to give informed consent\n  * Mechanical ventilation due to respiratory failure and\u002For need for renal replacement therapy and or requiring inotropes for circulatory support with a noradrenaline requirement of \\>0.5ug\u002Fkg\u002Fmin to maintain mean arterial pressure \\> 70mmHg\n  * Subject has received any investigational drug within 30 days of randomization\n  * Subject has any of the following conditions:\n\n    * history of liver transplantation\n    * postoperative decompensation after partial hepatectomy\n    * liver failure without underlying chronic liver injury\n  * Any untreated infections (\\\u003C48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV.\n  * Chronic or pre-existing kidney failure, survival prognosis of \\\u003C6 months due to severe co-morbid conditions that might confound study results or compromise subject safety\n  * Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anemia\n  * Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency.\n  * Active malignancy, premalignant hematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukemia) or multiorgan failure (≥ 4 organ failures).\n  * Pregnancy or nursing women\n  * Allergy to eggs","75 Years",{"count":51,"type":21},78,[53],"PHASE2","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.\n\nDescription 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) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a \\>15% risk of mortality at 28 days.\n\nPurpose of the study: The investigational medication, TAK-242, is aimed at stopping an \"over-reaction\" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol \\[severe alcoholic hepatitis (sAH)\\] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.",[56,57,58],"Acute-On-Chronic Liver Failure","Alcoholic Hepatitis","Liver Cirrhosis, Alcoholic",[60,61,62,63],"Novel combinatorial therapy","Improve hepatocyte proliferation","ACLF","Liver disease","2025-07-23",{"date":66,"type":33},"2025-07-29",{"date":68,"type":21},"2025-09-01",{"date":70,"type":21},"2026-12-31",{"name":39,"class":40},""]