This study is being conducted in patients who are hospitalized due to liver damage from alcohol abuse (Alcoholic Hepatitis AH). The purpose of this study is to see if the study drug, DUR-928 given in inpatient seeting is safe and effective in this group of patients.
Inclusion Criteria
- Male or female subjects over 18 years of age
- Onset of jaundice in the last 8 weeks before enrolling in the study
- Alcohol use of more than 40-60 grams for 6 months or more.
Exclusion Criteria
- Taking steroids for more than 8 days for treating your condition
- Receiving continuous veno-venous hemodialysis (CVVH)
- Positive urine drug screen
Study Requirements
This is a randomized trial, meaning you will be assigned to a group randomly ( like flipping a coin). You have a 66% chance of receiving the study drug and a 33% chance of receiving a placebo(sterile water).
If you agree to aprticpate in the study, you will be asked to sign a consent form. The study lasts for about 90 days from the time you sign the consent form.
There are 15 study visits in total. The first visit is called Screening visit and can last for about 4 days. During this visit, your blood and urine samples will be collected and a breath test to detect alcohol levels in your body will be done. Blood will be collected to test for HIV,Hepatitis B and C. Urine will be collected for drug screen and pregnancy (for females only).
If you are eligible after screening, you will be assigned to one group as described above. The study drug is given by means of an injection through your veins.
Certain visits can be conducted by phone call or in your home. For the in-person visits, there will be additional blood and urine samples collected per study requirement. Details of amount of blood to be collected and other study aspects will be provided to you by the study team.
