Health Condition 1: K701- Alcoholic hepatitis
Conditions
Interventions
Intervention1: Ursodiol injection, standard of care (SOC) and supportive therapy (ST): Ursodiol injection 625mg/25ml (25mg/ml) at dose level s of 3500 mg/day + standard of care (SOC), which includes P
Sponsors
Shilpa Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Hypotension with BP 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality rate [Time Frame: Time to event up to 1 month]Timepoint: Time to event up to 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement of liver parameters [Time Frame: 60 days] Improvement in MELD Score and Maddreys Discriminant Function (MDF) score at 60 Days [Time Frame: 60 days] Estimation of safety of ursodiol injection [Time Frame: 60 Days] Mortality rate [Time Frame: Time to event up to 2 months] Death at 60 days. Life score Symptoms scoreTimepoint: 60 days | — |
Countries
India
Contacts
Public ContactP Veerendra Kumar
Osmania General Hospital
Outcome results
None listed