Multicentre, randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety, and tolerability of UCL-L1V in the treatment of hyperammonaemia in patients with acute liver failure

AIIMS0 个研究点目标入组 18 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Men and women ≥18 and ≤ 70 years;
•2.Acute liver failure, defined as the development of coagulopathy and encephalopathy in a subject without preexisting liver disease and illness of ≤ 4 weeks;
•3.Ammonia level > 100 mol/L (normal ≤50 mol/L);
•4.Written informed consent from the subject and/or authorized legal representative.

•1.History of cirrhosis; or liver disease of > 4 weeks duration;
•2.Cerebral oedema, or need for either mechanical ventilation or endotracheal intubation;
•3.Current evidence of alcoholic hepatitis, biliary obstruction, malarial hepatopathy, or ischemic hepatitis;
•4.Anasarca or intractable ascites;
•5.Active bleeding;
•6.Haemodynamic instability, defined by a mean arterial pressure of <60mmHg or the requirement for inotropes;
•7.Cardiopulmonary complications (such as pulmonary oedema, aspiration pneumonia, heart failure);
•8.Creatinine ≥ 1.5 mg/dL;
•9.Pregnancy by serum pregnancy test or ultrasound ;
•10.Hepatic or extrahepatic malignancy within the past five years
•11.Focal neurologic signs;
•12.Non-hepatic causes of altered mental status;
•13.Recent (<1 week) administration of any sedative drug;
•14. Treatment with L-ornithine L-aspartate (LOLA), lactulose, or other ammonia lowering therapies;
•15.Concomitant drug administration that is known to interfere with metabolism of either ornithine, phenylacetate or both, such as antibiotics of the penicillin group and valproic acid;
•16. Prior history of HIV with an AIDS-defining event;
•17. Other major physical or major psychiatric illness that in the opinion of the investigator would affect the subject?s ability to participate in the trial.

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