Evaluation of efficacy and safety of â??SHL 1055â?? in Liver Disorder Patients with Abnormal Liver Function Test (LFT)- An open labeled, multicenter, non-comparative, interventional, prospective clinical study - NI

SAVESTA LIFESCIENCES INC0 个研究点目标入组 0 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). Diagnosis of hepatic disorder with abnormal LFT (Serum total bilirubin level greater than or equal to 2 mg/dl, or AST or ALT greater than 2 times ULN) with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain or feeling of pressure
•2).Subjects with abnormal LFT (Serum total bilirubin level greater than or equal 2 mg/dl, or AST or ALT greater than 2 times ULN) with or without fatty liver changes observed in Ultrasonography of abdomen will be enrolled in the study.
•3).Serum total bilirubin level greater than or equal 2 mg/dl, or AST or ALT greater than 2 times ULN
•4).A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
•5).Subjects willing to practice effective method of contraception during study period
•6).Subjects willing to sign inform consent form

•1)Duration of clinically apparent jaundice greater than 3 months
•2)Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis
•B or C) and Biliary obstruction
•3)Previous entry into the study, or use of either prednisolone or PTX within 6 weeks of admission
•4)AST greater than 500 U/L or ALT greater than 300 U/L
•5)Suspected hypersensitivity to contents of study drug
•6)Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer)
•7)Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer
•8)Patients with a renal failure
•9)Pregnant or lactating women
•10)Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol

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