A study to evaluate safety and efficacy of intravenous Ursodiol injection (25mg/ml) in severe Alcoholic Hepatitis patients
- Conditions
- Health Condition 1: K701- Alcoholic hepatitis
- Registration Number
- CTRI/2022/03/041331
- Lead Sponsor
- Shilpa Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 � 7 kpa and AST and ALT levels � 1.5 times upper normal limit (UNL).
5.Model for End-Stage Liver Disease (MELD) � 20 and Maddrey MDF � 32 will be enrolled for the study
1.Hypotension with BP < 80/50 after volume repletion
2.Signs of uncontrolled systemic infection: Fever > 38�°C and positive blood or ascites cultures and on appropriate antibiotic therapy for 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality rate [Time Frame: Time to event up to 1 month]Timepoint: Time to event up to 1 month
- Secondary Outcome Measures
Name Time Method Clinical improvement of liver parameters [Time Frame: 60 days] <br/ ><br>Improvement in MELD Score and Maddreys Discriminant Function (MDF) score at 60 Days [Time Frame: 60 days] <br/ ><br>Estimation of safety of ursodiol injection [Time Frame: 60 Days] <br/ ><br>Mortality rate [Time Frame: Time to event up to 2 months] Death at 60 days. <br/ ><br>Life score <br/ ><br>Symptoms scoreTimepoint: 60 days