A Prospective, Multi-centre, Double-blind, Randomized Trialof Saroglitazar 4 mg versus Placebo in Patients WithAlcoholic Liver Disease.

Cadila Healthcare Ltd0 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

研究概览

暂无简介。

•1)Heavy alcohol consumption (defined as >20 grams per day on average in women and > 60
•grams per day on average in men for a minimum of 6 months and within the 6 weeks prior
•to study enrollment).
•2)Should meet the following criteria in the FibroMax test:
•2a) Fibro Test (for hepatic fibrosis): Grades F1, F2 and F3.
•2b) Steato Test (for hepatic steatosis): Grades S1 and S2.
•2c) Ash Test (for alcoholic steatohepatitis): Grades H1 and H2.
•3)Ability to understand and give informed consent for participation

•1)Patients with severe alcoholic liver disease as determined by the following criteria:
•a) Maddrey discriminant function (DF) score more than 32.
•b) Model for end stage liver disease (MELD) score >=14
•2)Will be excluded if the patient meets the following criteria in the FibroMax test.
•2a) Fibro Test (for hepatic fibrosis):Grades F0 and F4.
•2b) Steato Test (for hepatic steatosis): Grades S0 and S3.
•2c) Ash Test (for alcoholic steatohepatitis): Grades H0 and H3.
•3)Severe renal impairment (Estimated glomerular filtration rate below 60 ml/min per 1.73m2).
•4)Uncontrolled upper gastrointestinal tract bleeding.
•5)AST and ALT values more than 400 IU/L.
•6)Participants on hepatotoxic medications like antitubercular medication, antiviral medication,
•7)Pregnant, attempting to conceive, or lactating women.
•8)Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days prior to screening.

发起方