An open label, evaluation of safety and efficacy of intravenous Ursodiol injection 625mg/25ml (25mg/ml) in severe Alcoholic Hepatitis patients

Shilpa Medicare Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1.Age between 21-70 years of patients.
•2.Recent alcohol consumption > 50g/day for > 6 months, continuing within two months before enrollment
•3.At least 2 of the following symptoms of acute alcoholic hepatitis: Anorexia, nausea, Right upper quadrant (RUQ) pain.
•4.Ultrasound scan confirmed severe hepatitis with fibro scan score Ã¢â?°Â¥ 7 kpa and AST and ALT levels Ã¢â?°Â¥ 1.5 times upper normal limit (UNL).
•5.Model for End-Stage Liver Disease (MELD) Ã¢â?°Â¥ 20 and Maddrey MDF Ã¢â?°Â¥ 32 will be enrolled for the study

•1.Hypotension with BP < 80/50 after volume repletion
•2.Signs of uncontrolled systemic infection: Fever > 38Ã?Â°C and positive blood or ascites cultures and on appropriate antibiotic therapy for Ã¢â?°Â¥ 3 days within 3 days of inclusion
•3.Acute gastrointestinal bleeding requiring >2 units blood transfusion within the previous 4 days
•4.Patients Positive with HBsAg and HCV antibody
•5.History of treatment for tuberculosis; history of any malignancy except skin cancer but including hepatocellular carcinoma within the last five years;
•6.Patients with positive HIV infection
•7.Recent previous treatment with corticosteroids or other immunosuppressive medications including specific anti-TNF therapy, calcineurin inhibitors within the previous 3 months.
•8.Treatment with corticosteroids for >3 days within 3 days of Inclusion .
•9.Serious cardiac, respiratory or neurologic disease or evidence of other liver diseases such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, secondary iron overload due to chronic hemolysis, alpha-1-antitrypsin deficiency.
•10.Acute or chronic kidney injury with serum creatinine > 3.0 mg/dl
•11.Patients with COVID-19 positive.

发起方