Phase II, double-blind, randomized, placebo-controlled, multicentre study to evaluate the safety, efficacy, and pharmacokinetics of TAK-242 and Granulocyte Colony-Stimulating Factor (G-CSF) (G-TAK) in subjects with severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF)

Yaqrit Ltd0 个研究点目标入组 78 人开始时间: 2022年12月5日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•1. Male and female subjects =18 years of age and =75 years of age
•2. With a diagnosis of severe alcoholic hepatitis defined by a Lille score of >0.45 in those treated with steroids and/or contraindication to steroids
•3. 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

•1. Refusal to give informed consent
•2. 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 >0.5 ug/kg/min to maintain mean arterial pressure >70 mmHg
•3. Subject has received any investigational drug within 30 days of randomization
•4. Subject has any of the following conditions:
•4.1. History of liver transplantation
•4.2. Postoperative decompensation after partial hepatectomy
•4.3. Liver failure without evidence of underlying chronic liver disease
•5. Any untreated infections (<48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV
•6. 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
•7. Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anaemia
•8. Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency
•9. Active malignancy, premalignant haematological disorders (e.g. myelodysplastic syndrome, chronic myeloid leukaemia) or multiorgan failure (=4 organ failures)
•10. Pregnancy or nursing women

发起方