- Alcoholic hepatitis
A Phase II, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH) (GS-US-416-2124) (IRB no. 46292)
This study focuses on patients who have severe alcoholic hepatitis (AH). AH is an inflammatory condition of the liver caused by excessive alcohol consumption over an extended period of time. The purpose of the study is to test an experimental drug called GS-4997 for the treatment of severe AH. Researchers aim to evaluate the effects of GS-4997 and determine whether GS-4997 in combination with prednisolone is safer and more effective for the treatment of AH than prednisolone alone.
Corticosteroids like prednisolone are the current standard of care for helping reduce the inflammatory process. GS-4997 has been shown to block chemical pathways in the liver that lead to inflammation of the liver cells. Its mechanism of action is complimentary to prednisolone.
Key Inclusion Criteria
- 18-70 years old
- Clinical diagnosis of severe AH
- Women of childbearing potential must agree to use a highly effective method of contraception.
Key Exclusion Criteria
- Pregnant or lactating females
- Other causes of liver disease including chronic hepatitis B, chronic hepatitis C, acetaminophen hepatotoxicity, biliary obstruction and autoimmune liver disease
- History of liver transplantation
- Taking prednisolone/prednisone or other corticosteroids at the time of screening
Vinay Sundaram, MD